Case Info
Boston Scientific Accolade Pacemaker Recall Lawsuit
The 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.
Serious Complications from Defective Accolade Pacemakers
The affected Boston Scientific pacemakers have a manufacturing defect with the battery cathode that can cause the device to enter Safety Mode under certain conditions. This issue potentially affects approximately 156,000 devices worldwide (about 13% of total units) that were manufactured before September 2018.
Affected devices include:
- ACCOLADE DR Pacemaker (Model Numbers L301, L311, L321, L331)
- PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber pacemakers
- VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)
Product Names:
- ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers
- VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)
Model:
-
- ACCOLADE DR Pacemaker, SL (Model Number L301)
- SL MRI (Model Number L311)
- EL (Model Number L321)
- EL MRI (Model Number L331)
- Unique Device Identifier (UDI)/Lot/Serial Numbers:
When a device enters Safety Mode, it cannot be reversed and only provides unipolar sensing and pacing rather than the programmed therapy designed for the patient’s specific cardiac needs.
The use of devices with this malfunction can cause:
- Abnormally slow heartbeats (bradycardia)
- Fainting episodes (syncope)
- Need for emergency surgery for device replacement
- Cardiac complications
- Death
Boston Scientific said that the risk of this failure occurring increases as the device enters the final four years of its projected lifetime.
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.