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# FDA Alert on Boston Accolade Pacers Early Replacement
- URL: https://www.fdaweb.com/fda-alert-on-boston-accolade-pacers-early-replacement/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158393

FDA says there is a potential need for early device replacement of Boston Scientific’s Accolade pacemakers. An agency [safety communication](https://www.fda.gov/medical-devices/safety-communications/accolade-pacemaker-devices-boston-scientific-and-potential-need-early-device-replacement-fda-safety?ref=fdaweb.com) says the company recalled a subset of Accolade pacemaker devices with an increased risk of permanently entering Safety Mode, which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients.

“A device that enters Safety Mode should be replaced,” the notice says. “The increased risk of permanently entering Safety Mode in this subset of Accolade pacemaker devices is due to the battery underpowering the system because of a manufacturing issue.”