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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":"2026-03-17","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System","security_title":null,"status":"ACTIVE_NOT_RECRUITING","accession_number":"NCT05501873","excerpt":"[\"Atrial Fibrillation\"]","importance":25},{"ts":"2026-03-02","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study","security_title":null,"status":"COMPLETED","accession_number":"NCT06526546","excerpt":"[\"Paroxysmal Atrial Fibrillation\"]","importance":25},{"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":"2026-01-21","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation","security_title":null,"status":"COMPLETED","accession_number":"NCT03729830","excerpt":"[\"Paroxysmal Atrial Fibrillation\"]","importance":25},{"ts":"2026-01-14","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Artificial Urinary Sphincter Clinical Outcomes","security_title":null,"status":"COMPLETED","accession_number":"NCT04088331","excerpt":"[\"Stress Urinary Incontinence\"]","importance":25},{"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":"2025-12-11","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Coordinated Reset Deep Brain Stimulation","security_title":"NA","status":"COMPLETED","accession_number":"NCT03732898","excerpt":"[\"Parkinson's Disease (PD)\"]","importance":25},{"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":"2025-12-03","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Clinical Trial of EPASS With Hot AXIOS System","security_title":"NA","status":"COMPLETED","accession_number":"NCT05644951","excerpt":"[\"Gastric Outlet Obstruction\"]","importance":25},{"ts":"2025-12-02","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)","security_title":null,"status":"COMPLETED","accession_number":"NCT05282823","excerpt":"[\"Paroxysmal Atrial Fibrillation\"]","importance":25},{"ts":"2025-11-25","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH","security_title":"NA","status":"COMPLETED","accession_number":"NCT02683980","excerpt":"[\"Treatment of Benign Prostatic Hyperplasia\"]","importance":25},{"ts":"2025-11-04","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"HEAL-LAA Clinical Trial","security_title":"NA","status":"COMPLETED","accession_number":"NCT05809596","excerpt":"[\"Atrial Fibrillation\",\"Bleeding\",\"Stroke\"]","importance":25},{"ts":"2025-09-18","kind":"clinical.trial","reporter":"Boston Scientific Corporation","title":"Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation","security_title":"NA","status":"COMPLETED","accession_number":"NCT03795298","excerpt":"[\"Atrial Fibrillation\"]","importance":25},{"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}]}