Boston Scientific Pacemakers
Boston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
Contact your healthcare provider to determine if your device requires the software update. Do not delay seeking medical care. Your doctor can advise on the appropriate next steps.
Why it was recalled
Boston Scientific is updating software for certain ACCOLADE, ESSENTIO, PROPONENT, and ALTRUA 2 pacemakers and CRT-Ps due to a bradycardia software maintenance release. The update addresses potential performance issues in dual-chamber and extended-life devices.
Is mine affected?
This recall covers the products below. If you have any of them, yours is affected.
| Product | Recall # |
|---|---|
| Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as | Z-1771-2026 |
| 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 Pac | Z-1770-2026 |
| Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as | – |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification