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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. 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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":"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}]}