By Mariah Taylor

Boston Scientific issued a recall involving a correction on all 27 Accolade pacemakers and CRT-Ps, according to a May 7 FDA news release. The agency identified the recall as Class I.

Here is what to know.

1. A battery issue can cause the devices to permanently enter safety mode, which limits functionality and may leave the pacemaker unable to properly regulate heart rhythm.

2. The FDA reported 2,557 serious injuries and four deaths related to this issue.

3. The recall involves correcting devices — not removing them from where they are used or sold. The FDA warns that the device may cause serious injury or death if it continues to be used without correction.

4. Boston Scientific is recommending all affected devices be upgraded to Brady SMR6 software and that physicians update the medical record for each patient with an affected device to ensure continuous awareness throughout the device’s remaining life.

5. In February 2025, the company recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement. In December 2024, the FDA issued a safety alert for some Boston Scientific Accolade pacemakers after reports of a battery-related manufacturing issue causing the devices to initiate safety mode.