FDA updates Boston Scientific’s Accolade pacemaker recall, reporting 832 injuries

Boston Scientific's recall of Accolade pacemakers has been updated with new information from the FDA, revealing a significant increase in reported adverse events.

Key Facts

The FDA has classified the recall as Class I, its most serious category, indicating potential for serious injury or death1 4.
832 injuries and two deaths have now been linked to the recalled devices1 3 4.
Approximately 203,000 devices globally are affected by the recall3.

- The recall impacts several pacemaker models:
Accolade, Proponent, Essentio, Altrua 2, Visionist and Valitude1 2.

Reason for Recall

The recall is due to a manufacturing issue that can cause the pacemakers to:

Permanently enter "Safety Mode"2 3
Have limited functionality2
Fail to properly regulate heart rhythm3
Require replacement1

FDA Recommendations

The FDA advises:

Patients should work with healthcare providers to monitor devices4
Remote monitoring should be used when possible4
Regular in-office monitoring if remote monitoring isn't feasible3
Immediate device replacement if it enters Safety Mode and the patient is at high risk5

Timeline

- December 2024:
Boston Scientific initially issued the recall2 6

- February 2025:
FDA classified the recall as Class I and updated injury/death statistics1 4

This update highlights the serious nature of the recall and the importance of close monitoring for affected patients. Healthcare providers and patients should follow FDA recommendations to ensure proper management of these devices.