Pacemaker Correction: Boston Scientific Issues Correction For Accolade Pacemakers And Crt-ps

Boston Scientific has issued a correction for ACCOLADE pacemakers and CRT-Ps (cardiac resynchronization therapy pacemakers) to make available Brady SMR6, which is now compatible with these devices. The correction also expands to include additional CRT-P and DR-EL device models that were not previously covered. This affects patients who have these specific pacemaker models implanted.

Product
ACCOLADE Pacemakers and CRT-Ps
Reason
Brady SMR6 is now available for ACCOLADE pacemakers and CRT-Ps; correction expanded to include CRT-P and DR-EL devices.
Category
medical device recall
Country
United States
Agency
FDA-MEDWATCH-RSS
Recall date
2026-05-07
Status
Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/06e14eb2-f198-4734-9511-9d6c1ffe4e92