Boston Scientific ACCOLADE/ESSENTIO/PROPONENT/ALTRUA 2 Pacemakers
Boston Scientific expands pacemaker software advisory to include CRT-P and DR-EL devices; SMR6 update addresses dual-chamber pacing issues.
Contact your healthcare provider to determine if your device requires the Brady Software Maintenance Release 6 (SMR6) update. Do not stop using your pacemaker without consulting a physician.
Why it was recalled
Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and CRT-Ps to include all CRT-P and dual-chamber extended life (DR-EL) devices. The Brady Software Maintenance Release 6 (SMR6) addresses potential issues in dual-chamber pacing modes for conduction disorders, VVI intolerance, and bradycardia-related low cardiac output.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| 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 | – |
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification