Boston Scientific Accolade Pacemaker Recall Lawsuit
Did you or a loved one experience injury or death as a result of your defective Accolade family pacemaker, or require replacement or repair of your defective pacemaker?
You may be eligible for compensationThe U.S. Food and Drug Administration (FDA) has issued its most serious Class I recall for certain Boston Scientific Accolade family pacemakers due to a manufacturing defect that may cause the devices to enter an irreversible “Safety Mode,” causing device failure or requiring early device replacement. As of February 2025, this defect has been linked to 832 reported injuries and 2 deaths.
Patients who experienced serious cardiac complications such as slow heartbeats (bradycardia), fainting (syncope), or required early device replacement surgery due to a Boston Scientific Accolade pacemaker entering Safety Mode may be eligible for compensation. Family members of patients who died as a result of these pacemaker malfunctions may also qualify for wrongful death claims.
FDA Class I Recall and Safety Communication
On December 16, 2024, the FDA issued a Safety Communication regarding Boston Scientific’s Accolade pacemaker devices. On February 21, 2025, the FDA upgraded this to a Class I recall—its most serious type—indicating that use of these devices may cause serious injury or death.
Boston Scientific initially notified all affected customers on December 12, 2024, with an Urgent Medical Device Information letter recommending immediate device replacement for high-risk patients whose devices entered Safety Mode, and non-urgent replacement for other affected patients.
The FDA has advised patients with these devices to:
- Continue working with healthcare providers to monitor the device
- Consider remote monitoring options
- Discuss potential risks with healthcare providers
- Report any symptoms such as lightheadedness or loss of consciousness
- Contact healthcare providers about potential device replacement if determined to be at high risk
If you or a loved one were implanted with a Boston Scientific Accolade family pacemaker before September 2018 and experienced complications or required early device replacement surgery, you may be entitled to compensation.