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  5. Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication
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Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication

Date Issued: December 16, 2024

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about the potential need for early device replacement of Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers.

Boston Scientific announced a recall for a subset of Accolade pacemaker devices with an increased risk to permanently enter Safety Mode, which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients. A device that enters Safety Mode should be replaced. The increased risk of permanently entering Safety Mode in this subset of Accolade pacemaker devices is due to the battery underpowering the system because of a manufacturing issue.  

While the recall by Boston Scientific identifies a subset of Accolade pacemaker devices with increased risk of entering Safety Mode, the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices and identify additional mitigation strategies as needed. 

The FDA is issuing this communication to raise awareness of the manufacturer’s recall notice, the FDA’s ongoing evaluation with the manufacturer of the issue, and the FDA’s current recommendations.

Recommendations for Patients and Caregivers

  • 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.

Recommendations for Health Care Providers

  • Review the recall notice from Boston Scientific for a subset of Accolade pacemaker devices with an increased risk to permanently enter Safety Mode due to the battery underpowering the system because of a manufacturing issue with the battery cathode. The recall notice includes the following important information:
    • Description of the battery problem and clinical impact of Safety Mode,
    • Recommended actions for individual patient evaluation, device replacement, and follow-up intervals, and
    • Model numbers and Unique Device Identifier (UDI) information. 
  • Be aware that the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices.
    • Consider the potential need for early device replacement and a patient’s specific reliance on their pacemaker when making treatment recommendations.
    • Discuss the benefit and risks of all available treatment options with your patients. 
    • Remain alert for further updates and recommendations from the FDA and the manufacturer.
    • While the FDA’s evaluation is ongoing, health care providers should:
      • Monitor patients with Accolade pacemaker devices through remote or in-office visits for red box alerts indicating that a patient’s device is in Safety Mode, or symptoms indicating device performance issues, such as lightheadedness or loss of consciousness. General prophylactic device replacement is not recommended. 
      • If monitoring indicates that the device has entered Safety Mode, schedule surgery for a replacement pacemaker. Timely replacement is recommended to avoid risks associated with time spent in Safety Mode.
  • Report any problems your patients experience with Accolade pacemaker devices to the FDA.

Device Description

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.

Potential Need for Early Device Replacement of Accolade Pacemaker Devices

The FDA is aware of a manufacturing issue with the cathode of some Accolade pacemaker device batteries that may lead to underpowering the device system and may cause the pacemakers to permanently enter Safety Mode, which requires pacemaker replacement.

Pacemakers that enter Safety Mode require replacement because Safety Mode offers limited functioning of the pacemaker and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients. Safety Mode can only be identified through office visits or through remote monitoring using the Boston Scientific Latitude Communicator system.

The manufacturer plans to implement updated manufacturing work instructions for the process used to make the cathodes for Accolade product batteries. In addition, the manufacturer is developing a software update to detect battery health in all Accolade pacemaker devices.

FDA Actions

The FDA will continue working with Boston Scientific to help ensure that patients, caregivers, and providers are aware of the issue, evaluate information to better understand the issue, and to identify additional mitigation strategies as needed.    

The FDA will continue to monitor information about device performance including medical device reports.

The FDA will keep the public informed as new information becomes available.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

Reporting Problems with Your Pacemaker

If you think you had a problem with your pacemaker, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, contact CDRH's Division of Industry and Consumer Education (DICE).

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