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There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.","accession_number":"Z-2725-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.","excerpt":"Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects \"Recalculate\",  the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.","accession_number":"Z-2771-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062","excerpt":"Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.","accession_number":"Z-2755-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter","excerpt":"Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.","accession_number":"Z-2753-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter","excerpt":"Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.","accession_number":"Z-2750-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter","excerpt":"Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.","accession_number":"Z-2751-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter","excerpt":"Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.","accession_number":"Z-2752-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01","excerpt":"Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.","accession_number":"Z-2757-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01","excerpt":"Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.","accession_number":"Z-2754-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-06-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01","excerpt":"Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.","accession_number":"Z-2756-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Pro Wireguided 12-15mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2629-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Pro Wireguided 10-12mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2628-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Pro Wireguided 15-18mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2630-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Pro Wireguided 6-8mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2626-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Wireguided 8-10mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2633-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Wireguided 12-15mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2635-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Wireguided 15-18mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2636-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Wireguided 6-8mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2632-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Wireguided 18-20mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2637-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Pro Wireguided 8-10mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2627-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Wireguided 10-12mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2634-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-21","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CRE Pro Wireguided 18-20mm 240cm","excerpt":"Potential sterile breach of the pouches in which devices are packaged.","accession_number":"Z-2631-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-12","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.","excerpt":"Boston Scientific is initiating a medical device removal of  Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.","accession_number":"Z-2413-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-05-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device","excerpt":"There is the potential for leakage along the drug pathway from the pump through the end of the catheter.","accession_number":"Z-2580-2026","status":"Completed","product_type":"device","importance":60},{"ts":"2026-05-06","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE","security_title":"NA","status":"SUSPENDED","accession_number":"NCT06174805","excerpt":"Sponsor Decision","importance":80},{"ts":"2026-04-27","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)","security_title":"PHASE3","status":"ACTIVE_NOT_RECRUITING","accession_number":"NCT04647253","excerpt":"[\"In-Stent Restenosis\"]","importance":60},{"ts":"2026-04-27","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort","security_title":"PHASE3","status":"ACTIVE_NOT_RECRUITING","accession_number":"NCT06492174","excerpt":"[\"In-Stent Restenosis\"]","importance":60},{"ts":"2026-04-17","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis","security_title":"NA","status":"SUSPENDED","accession_number":"NCT06750146","excerpt":"Sponsor decision","importance":80},{"ts":"2026-04-08","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"MANDARIN (S6371)","security_title":"PHASE3","status":"ACTIVE_NOT_RECRUITING","accession_number":"NCT05016245","excerpt":"[\"Inoperable Hepatocellular Carcinoma\"]","importance":60},{"ts":"2026-03-30","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5","excerpt":"For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.","accession_number":"Z-2048-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-03-30","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5","excerpt":"For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.","accession_number":"Z-2049-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2026-03-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228.","excerpt":"Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.    Dual chamber modes are specifically indicated for treatment of the following:    \" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block    \" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm    \" Low cardiac output or congestive heart failure secondary to bradycardia","accession_number":"Z-1771-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2026-03-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as:    1. ESSENTIO SR SL, Model Number L100;   2. ESSENTIO DR SL Pacemaker, Model Number L101;   3. ESSENTIO SR SL MRI Pacemaker, Model Number L110;   4. ESSENTIO DR SL MRI Pacemaker, Model Number L111;   5. ESSENTIO DR EL Pacemaker, Model Number L121;   6. ESSENTIO DR EL MRI Pacemaker, Model Number L131;   7. PROPONENT SR SL Pacemaker, Model Number L200;   8. PROPONENT DR SL Pacemaker, Model Number L201;   9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209;   10. PROPONENT SR SL Pacemaker, Model Number L210;   11. PROPONENT DR SL MRI Pacemaker, Model Number L211;   12. PROPONENT DR EL Pacemaker, Model Number L221;   13. PROPONENT DR EL MRI Pacemaker, Model Number L231*;   14. ACCOLADE SR SL Pacemaker, Model Number L300;   15. ACCOLADE DR SL Pacemaker, Model Number L301;   16. ACCOLADE SR SL MRI Pacemaker, Model Number L310;   17. ACCOLADE DR SL MRI Pacemaker, Model ","excerpt":"Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.    Dual chamber modes are specifically indicated for treatment of the following:    \" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block    \" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm    \" Low cardiac output or congestive heart failure secondary to bradycardia","accession_number":"Z-1770-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2026-02-10","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"EndoVive Safety PEG Kit;  Outer Box Material Number (UPN): M00509001;  Inner Box Material Number (UPN): M00509000;","excerpt":"Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit  components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.","accession_number":"Z-1551-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-12-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   6mm x 8mm;  Material Number (UPN): M00553520;","excerpt":"Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.","accession_number":"Z-1161-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-12-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;  Material Number (UPN): M00553660;","excerpt":"Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.","accession_number":"Z-1158-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-12-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm;  Material Number (UPN): M00553560;","excerpt":"Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.","accession_number":"Z-1163-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-12-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;  Material Number (UPN): M00553680;","excerpt":"Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.","accession_number":"Z-1159-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-12-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   8mm x 8mm;  Material Number (UPN): M00553530;","excerpt":"Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.","accession_number":"Z-1162-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-12-19","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;  Material Number (UPN): M00553690;","excerpt":"Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.","accession_number":"Z-1160-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-12-03","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal","excerpt":"Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.","accession_number":"Z-1042-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"TENACIO Pump without InhibiZone;  UPN: 72404420;","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0139-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"TENACIO Pump with InhibiZone;  UPN: 72404429;","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0138-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"LGX Preconnect with TENACIO Pump without InhibiZone;  UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0141-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CXR Preconnect with TENACIO Pump with InhibiZone;  UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0143-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CX Preconnect with TENACIO Pump without InhibiZone;  UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0140-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"LGX Preconnect with TENACIO Pump with InhibiZone;  UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0144-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-09-11","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"CX Preconnect with TENACIO Pump with InhibiZone;  UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);","excerpt":"The potential for devices to experience inflation and/or deflation performance issues or difficulties.","accession_number":"Z-0142-2026","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-08-28","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"Extractor Pro RX Retrieval Balloon Catheter;  UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);","excerpt":"The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.","accession_number":"Z-2618-2025","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L211 PROPONENT DR SL MRI Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0089-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number S702, ALTRUA 2 DR SL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0099-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number U128, VALITUDE CRT-P EL MRI","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0102-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L231, PROPONENT DR EL MRI Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0091-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L101, ESSENTIO DR SL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0093-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L209 PROPONENT DR (VDD) SL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0087-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number U226, VISIONIST CRT-P EL","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0104-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"PROPONENT SR SL (Model L200)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0085-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number U228, VISIONIST CRT-P EL MRI","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0105-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L221 PROPONENT DR EL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0090-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L131, ESSENTIO DR EL MRI Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0097-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"ACCOLADE DR EL MRI (Model L331)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0084-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L121 ESSENTIO DR EL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0096-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L110, ESSENTIO SR SL MRI Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0094-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number U225 VISIONIST CRT-P EL","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0103-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L210 PROPONENT SR SL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0088-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"ACCOLADE DR SL (Model L301)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0080-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"ACCOLADE DR EL (Model L321)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0083-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number S701 ALTRUA 2 SR SL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0098-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L111, ESSENTIO DR SL MRI Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0095-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"ACCOLADE SR SL (Model L300)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0079-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number U125, VALITUDE CRT-P EL","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0101-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number L100, ESSENTIO SR SL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0092-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"ACCOLADE SR SL MRI (Model L310)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0081-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"PROPONENT DR SL (Model L201)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0086-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"Model Number S722, ALTRUA 2 DR EL Pacemaker","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0100-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-20","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class I","security_title":"ACCOLADE DR SL MRI (Model L311)","excerpt":"Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state   for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).","accession_number":"Z-0082-2026","status":"Ongoing","product_type":"device","importance":100},{"ts":"2025-08-18","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000","excerpt":"Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.","accession_number":"Z-2550-2025","status":"Ongoing","product_type":"device","importance":60},{"ts":"2025-08-18","kind":"fda.recall","reporter":"Boston Scientific Corporation","title":"Class II","security_title":"Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000","excerpt":"Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.","accession_number":"Z-2551-2025","status":"Ongoing","product_type":"device","importance":60},{"ts":"2024-12-31","kind":"open.payments","reporter":"Boston Scientific Corporation","title":"$49002919.0 to 68994 physicians (2024–2024)","security_title":"manufacturer","excerpt":"WATCHMAN Access System","accession_number":"2024","usd_value":49002919,"importance":70}]}