Boston Scientific Accolade Pacemaker – Class Action Investigation

Do You or a Loved One Have a Boston Scientific Accolade Family Pacemaker and Experienced Injury or Required Repair or Replacement? 

Chimicles Schwartz Kriner & Donaldson-Smith is actively investigating potential class action claims on behalf of individuals who have had implanted a Boston Scientific Accolade family pacemaker and subsequently suffered injury or death and/or required repair or replacement of the device. 

What is the Accolade pacemaker? 

The ACCOLADE family of pacemakers is designed to treat slow heart rhythms by providing dual-chamber and adaptive rate pacing. 

What is the Recall? 

On February 21, 2025, the FDA issued a Class 1 recall, its most serious designation for recalls, for certain Boston Scientific Accolade family pacemakers manufactured before September 2018 indicating the use of these devices may cause serious injury or death. The recall is due to a manufacturing defect found in the battery that may cause the devices to enter into an irreversible “safety mode” causing device failure or requiring each device replacement.  The FDA has linked this defect to a significant number of adverse events, including 832 reported injuries and 2 deaths as of February 2025.  

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 followed up with a Safety Communication on December 16.  

Which Devices are Affected?  

The defect potentially affects approximately 156,000 devices worldwide (about 13% of total units) that were manufactured before September 2018 including: 

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)

Models: 

• ACCOLADE DR Pacemaker, SL (Model Number L301) 

• SL MRI (Model Number L311) 

• EL (Model Number L321) 

• EL MRI (Model Number L331) 

Serious Health Complications Reported as a Result of the Defect: 

• Abnormally slow heartbeats (bradycardia) 

• Fainting episodes (syncope) 

• The need for emergency surgery for device replacement 

• Other 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.  

If you or a loved one were implanted with a Boston Scientific Accolade family pacemaker before September 2018 and experienced complications such as those listed above, or required early device replacement, please reach out to us by filling-out the form provided below with details of your experience.