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  5. Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement
  1. Medical Device Recalls

Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement

The devices described in this recall are included in the related Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication.

This recall involves the potential need for device explant. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the What to Do section below. 

Affected Product

  • 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:

This population includes the following model numbers and GTINs; however, these attributes are not sufficient to identify devices in the advisory population. Reference Boston Scientific’s device lookup tool where patients and healthcare professionals can enter a model/serial to identify whether a specific device is included in this action.

GTINModelProduct Name
00802526558924L101ESSENTIO DR SL
00802526558931L101ESSENTIO DR SL
00802526571954L101ESSENTIO DR SL
00802526571961L101ESSENTIO DR SL
00802526576317L101ESSENTIO DR SL
00802526576812L101ESSENTIO DR SL
00802526558962L111ESSENTIO DR SL MRI
00802526558979L111ESSENTIO DR SL MRI
00802526572012L111ESSENTIO DR SL MRI
00802526572029L111ESSENTIO DR SL MRI
00802526576331L111ESSENTIO DR SL MRI
00802526576836L111ESSENTIO DR SL MRI
00802526558986L121ESSENTIO DR EL
00802526558993L121ESSENTIO DR EL
00802526572043L121ESSENTIO DR EL
00802526576348L121ESSENTIO DR EL
00802526593277L121ESSENTIO DR EL
00802526559006L131ESSENTIO DR EL MRI
00802526559013L131ESSENTIO DR EL MRI
00802526572081L131ESSENTIO DR EL MRI
00802526576355L131ESSENTIO DR EL MRI
00802526559044L201PROPONENT DR SL
00802526572135L201PROPONENT DR SL
00802526576379L201PROPONENT DR SL
00802526576874L201PROPONENT DR SL
00802526578014L201PROPONENT DR SL
00802526559068L209PROPONENT DR (VDD) SL
00802526576386L209PROPONENT DR (VDD) SL
00802526559105L211PROPONENT DR SL MRI
00802526572210L211PROPONENT DR SL MRI
00802526576409L211PROPONENT DR SL MRI
00802526576904L211PROPONENT DR SL MRI
00802526578038L211PROPONENT DR SL MRI
00802526559129L221PROPONENT DR EL
00802526572241L221PROPONENT DR EL
00802526576416L221PROPONENT DR EL
00802526578045L221PROPONENT DR EL
00802526593307L221PROPONENT DR EL
00802526559143L231PROPONENT DR EL MRI
00802526572272L231PROPONENT DR EL MRI
00802526576423L231PROPONENT DR EL MRI
00802526578052L231PROPONENT DR EL MRI
00802526559174L301ACCOLADE DR SL
00802526559181L301ACCOLADE DR SL
00802526572333L301ACCOLADE DR SL
00802526572340L301ACCOLADE DR SL
00802526576942L301ACCOLADE DR SL
00802526559228L311ACCOLADE DR SL MRI
00802526559235L311ACCOLADE DR SL MRI
00802526572395L311ACCOLADE DR SL MRI
00802526576461L311ACCOLADE DR SL MRI
00802526578076L311ACCOLADE DR SL MRI
00802526559242L321ACCOLADE DR EL
00802526559259L321ACCOLADE DR EL
00802526572425L321ACCOLADE DR EL
00802526593260L321ACCOLADE DR EL
00802526559266L331ACCOLADE DR EL MRI
00802526559273L331ACCOLADE DR EL MRI
00802526572456L331ACCOLADE DR EL MRI
00802526576485L331ACCOLADE DR EL MRI
00802526578083L331ACCOLADE DR EL MRI
00802526592201L331ACCOLADE DR EL MRI
00802526559358S702ALTRUA 2 DR SL
00802526572517S702ALTRUA 2 DR SL
00802526576508S702ALTRUA 2 DR SL
00802526577000S702ALTRUA 2 DR SL
00802526578106S702ALTRUA 2 DR SL
00802526593208S702ALTRUA 2 DR SL
00802526559365S722ALTRUA 2 DR EL
00802526559372S722ALTRUA 2 DR EL
00802526576515S722ALTRUA 2 DR EL
00802526577017S722ALTRUA 2 DR EL
00802526578113S722ALTRUA 2 DR EL
00802526593239S722ALTRUA 2 DR EL
00802526559389U125VALITUDE CRT-P EL
00802526559396U125VALITUDE CRT-P EL
00802526573101U125VALITUDE CRT-P EL
00802526573118U125VALITUDE CRT-P EL
00802526577024U125VALITUDE CRT-P EL
00802526577109U125VALITUDE CRT-P EL
00802526578793U125VALITUDE CRT-P EL
00802526559402U128VALITUDE CRT-P EL MRI
00802526559419U128VALITUDE CRT-P EL MRI
00802526572609U128VALITUDE CRT-P EL MRI
00802526572616U128VALITUDE CRT-P EL MRI
00802526576522U128VALITUDE CRT-P EL MRI
00802526577031U128VALITUDE CRT-P EL MRI
00802526578120U128VALITUDE CRT-P EL MRI
00802526593284U128VALITUDE CRT-P EL MRI
00802526559433U225VISIONIST CRT-P EL
00802526572630U225VISIONIST CRT-P EL
00802526577048U225VISIONIST CRT-P EL
00802526577116U225VISIONIST CRT-P EL
00802526578809U225VISIONIST CRT-P EL
00802526559457U226VISIONIST CRT-P EL
00802526559464U226VISIONIST CRT-P EL
00802526577062U226VISIONIST CRT-P EL
00802526577123U226VISIONIST CRT-P EL
00802526559488U228VISIONIST CRT-P EL MRI
00802526572692U228VISIONIST CRT-P EL MRI
00802526577130U228VISIONIST CRT-P EL MRI
00802526578830U228VISIONIST CRT-P EL MRI

What to Do

 On December 12, 2024, Boston Scientific Corporation sent all affected customers an Urgent Medical Device Information letter recommending the following actions for health care providers:

  • If a device enters Safety Mode, immediately replace the device in patients who are at high risk of harm associated with interrupted pacing that may occur with Safety Mode. Recommend non-urgent replacement for other patients.
  • Do not rely on battery life estimates in Safety Mode. This mode uses more power, decreases battery life and may cause incorrect battery life estimate.
  • For patients with certain devices, who are at risk if Safety Mode occurs:
    • Schedule device replacement promptly when the battery life remaining reaches four years or if the remaining battery life is already less than 4 years.
  • Conduct system follow-ups (remote or in-office) at least once every 12 months.

In addition, on December 16, 2024, the FDA issued an FDA Safety Communication with recommendations for patients, caregivers, and health care providers:

  • 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 GTINs are included in the letter; however, advisory device can only be identified by unique model and serial number combinations. Boston Scientific distributed a list of affected devices by model/serial in December 2024. If you need a list, contact your local Boston Scientific sales professional or check a specific device using Boston Scientific’s device lookup tool.
    • 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.

Reason for Recall

Boston Scientific Corporation is recalling devices due to a manufacturing issue that could cause the device to enter Safety Mode under certain conditions. If the device enters Safety Mode, early device replacement is needed. Safety Mode is an intended feature that activates during critical device component failures. When the device experiences three power-on resets within 48 hours due to battery issues, Safety Mode is initiated. Once a device enters Safety Mode, it cannot be reversed and may cause these devices to only provide unipolar sensing and pacing, which can lead to serious injury or death due to interruption of pacing.

Devices in the ACCOLADE family of pacemakers and CRT-Ps have an increased chance to enter Safety Mode during remote data collection (telemetry) or other higher-powered operations. Additionally, devices in Safety Mode must be removed and replaced.

The use of affected devices may cause serious adverse health consequences, including slow heartbeats (bradycardia), fainting (syncope), and death.

There have been 832 reported injuries. There have been two reports of death. 

Device Use

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

These devices include:

  • single-chamber pacemakers (SR) for ventricular or atrial pacing and sensing
  • dual-chamber pacemakers (DR) for both atrial and ventricular pacing and sensing
  • CRT-P devices, which offer therapies like cardiac resynchronization therapy (CRT) to manage heart failure by coordinating ventricular contractions through biventricular electrical stimulation. They also provide bradycardia pacing, including adaptive rate pacing, to detect and treat slow heart rhythms.

Contact Information

Customers in the U.S. with questions about this recall should contact Boston Scientific at 1-800-227-3422. 

Additional FDA Resources

Additional Company Resources

The advisory section of Boston Scientific’s Product Performance Report will include the latest information about this topic. Check to see if a specific device is included in this action by entering the model/serial in Boston Scientific’s device lookup tool.

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.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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