Accolade Pacemaker Recall Issued by Boston Scientific Due to Life-Threatening Injury Risks

More than 55,000 Accolade and Accolade Proponent pacemakers are being recalled due to a battery issue that may reduce device performance.

According to federal regulators, some Accolade and Accolade Proponent pacemakers may suddenly switch into Safety Mode, a limited-function state that could put patients at a serious risk.

The U.S. Food and Drug Administration (FDA) announced the Accolade pacemaker recall (PDF) on October 10, advising customers to upgrade the device software immediately.

A pacemaker is a small medical device implanted in the chest that helps control abnormal heart rhythms by sending electrical signals to keep the heart beating at a normal, steady rate when it is too slow or irregular.

Safety Mode is a backup feature in pacemakers that activates when the device detects a malfunction, such as a battery defect. While it maintains basic pacing to keep the heart beating, it disables important functions like rate responsiveness, remote monitoring and detailed data transmission. This loss of monitoring and tailored pacing can delay medical intervention and increase the risk of serious injury or death.

Boston Scientific notices were sent to providers and patients last month, addressing unexpected problems with the device’s software, including the failure to fully turn off wireless communication after detecting a battery issue, which could drain the battery faster. 

The notices also indicated that battery tests could be interrupted by nearby magnets, potentially triggering false alarms that disable wireless communication and lead to a loss of remote monitoring for patients.

This recall covers select Boston Scientific Accolade and Accolade Proponent Dual Chamber (DR) pacemakers, which pace two heart chambers, as well as Single Chamber (SR) models designed to pace only one. These devices are equipped with either standard-life (SL) or extended-life (EL) batteries and include:

• 7,488 Accolade DR EL devices (Model L321)
• 32,695 Accolade DR SL devices (Model L310)
• 16,077 Accolade SR SL devices (Model L300)
• 2,426 Proponent DR SL devices (Model L201)
• 1,380 Proponent SR SL devices (Model L200).

The current notice updates a prior “Urgent Medical Device Correction” issued by Boston Scientific on August 18, which followed a December 2024 communication warning that high battery resistance could cause pacemakers to enter Safety Mode by limiting the device’s ability to deliver power effectively.

Providers received an updated Medical Device Correction notice, and patients were sent a letter (PDF) last month, advising them to keep and attend all scheduled medical appointments and to talk with their doctor about the best steps for managing their pacemaker system. All customers are advised to upgrade the pacemaker software in a timely manner.

For additional information, Boston Scientific’s U.S. Technical Services can be contacted at 1-800-227-3422 or by email at tech.services@bsci.com.

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