FDA recall, , High risk
Boston Scientific Essentio, Proponent, Valitude and Visionist Pacemakers
Boston Scientific pacemakers may have a software issue that could affect therapy.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation of Saint Paul, Minnesota, is recalling its Cardiac Resynchronization Therapy (CRT) devices and pacemakers due to a software issue that could affect therapy. The advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices, with updated software, Brady software maintenance release 6 (SMR6), now available for the ACCOLADE family.
The recall began March 19, 2026, and was added to the FDA's Enforcement Report on April 24, 2026, with worldwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Check yours against the codes the FDA notice names.
Boston Scientific Cardiac Resynchronization Therapy (CRT)
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy)
Recall details
- Company began the recall
- Sold in
worldwide
- Company
- Boston Scientific CorporationSaint Paul, Minnesota
- Hazard
- Software defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98615
- Recall numbers
- Z-1770-2026 to Z-1771-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
