Boston Scientific Pacemaker Recall

What is the recall: The U.S. Food and Drug Administration (FDA) and Boston Scientific sent an alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers. This recall was updated on 03/03/25 to the most serious type of recall because of potential harm to patients with these devices implanted. These devices may need to be removed and replaced with new devices.

Who does it affect: The recall includes a subset of the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy (CRT) pacemakers.

Why are these devices recalled: The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.

The company said there was an unanticipated concentration of lithium salts resulting from variability of battery assembly techniques between workers. The higher amount of salts causes latent high battery impedance, which can initiate safety mode during telemetry or other normal, higher-power operations. 

How to check if it affects me: The Accolade devices are a family of pacemakers and cardiac resynchronization therapy pacemakers that are implanted to treat abnormal heartbeat (arrhythmia) and moderate to severe heart failure.

You can learn whether this is your device via the card that was given to you post-implantation. If you do have an affected device, reach out to your healthcare professional to discuss your next steps.

What should I do if it affects my device: If your device is affected by this recall, you should receive a letter in the mail or a call from your device clinic. If you have not received a letter or call, you should reach out to your clinic. 

What is being recommended:

• Continue to work with your health care provider to monitor your Accolade pacemaker device, either remotely or during your existing in-office follow-up schedule.
• Discuss with your health care provider if you are a candidate for remote monitoring. Remote monitoring enables your provider to receive regular updates, including a Safety Mode alert, from your device.
• If not a candidate for remote monitoring, discuss an in-office monitoring schedule with your health care provider to help ensure that your device is functioning properly.
• If monitoring indicates that your device entered Safety Mode, discuss a plan with your health care provider for surgery to replace the pacemaker.
• Discuss your current pacing needs and potential risk of your device entering Safety Mode with your health care provider.
• If you are determined to be at high risk of harm if your device entered Safety Mode based on your pacing needs, your health care provider may contact you about replacement of your device.
• Consult with your health care provider if you have new or worsening symptoms such as lightheadedness or loss of consciousness, or questions about your device potentially entering Safety Mode.

Report any problems with your Accolade pacemaker device to the FDA.

You can read more about the Boston Scientific recall here. And please feel free to contact us with any questions!