Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (non-crt)

Summary Boston Scientific is recalling multiple pacemaker models (including ESSENTIO, PROPONENT, ACCOLADE, and ALTRUA 2 series) distributed worldwide because updated software is now available for certain models. The recall expands a previous advisory to include all dual-chamber extended life devices and cardiac resynchronization therapy pacemakers that may be affected by the software update.

Recalling firm: Boston Scientific Corporation
Product: 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,...
Reason: 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...
Classification: Class III
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-03-19
Status: Open, Classified
Distribution: worldwide

Recall details on Nibble Recalls: https://trynibble.app/recalls/ed44504d-832c-4f48-8293-5e412a34a6d5