Boston Scientific Recalls Accolade Pacemakers

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.

GTIN	Model	Product Name
00802526558924	L101	ESSENTIO DR SL
00802526558931	L101	ESSENTIO DR SL
00802526571954	L101	ESSENTIO DR SL
00802526571961	L101	ESSENTIO DR SL
00802526576317	L101	ESSENTIO DR SL
00802526576812	L101	ESSENTIO DR SL
00802526558962	L111	ESSENTIO DR SL MRI
00802526558979	L111	ESSENTIO DR SL MRI
00802526572012	L111	ESSENTIO DR SL MRI
00802526572029	L111	ESSENTIO DR SL MRI
00802526576331	L111	ESSENTIO DR SL MRI
00802526576836	L111	ESSENTIO DR SL MRI
00802526558986	L121	ESSENTIO DR EL
00802526558993	L121	ESSENTIO DR EL
00802526572043	L121	ESSENTIO DR EL
00802526576348	L121	ESSENTIO DR EL
00802526593277	L121	ESSENTIO DR EL
00802526559006	L131	ESSENTIO DR EL MRI
00802526559013	L131	ESSENTIO DR EL MRI
00802526572081	L131	ESSENTIO DR EL MRI
00802526576355	L131	ESSENTIO DR EL MRI
00802526559044	L201	PROPONENT DR SL
00802526572135	L201	PROPONENT DR SL
00802526576379	L201	PROPONENT DR SL
00802526576874	L201	PROPONENT DR SL
00802526578014	L201	PROPONENT DR SL
00802526559068	L209	PROPONENT DR (VDD) SL
00802526576386	L209	PROPONENT DR (VDD) SL
00802526559105	L211	PROPONENT DR SL MRI
00802526572210	L211	PROPONENT DR SL MRI
00802526576409	L211	PROPONENT DR SL MRI
00802526576904	L211	PROPONENT DR SL MRI
00802526578038	L211	PROPONENT DR SL MRI
00802526559129	L221	PROPONENT DR EL
00802526572241	L221	PROPONENT DR EL
00802526576416	L221	PROPONENT DR EL
00802526578045	L221	PROPONENT DR EL
00802526593307	L221	PROPONENT DR EL
00802526559143	L231	PROPONENT DR EL MRI
00802526572272	L231	PROPONENT DR EL MRI
00802526576423	L231	PROPONENT DR EL MRI
00802526578052	L231	PROPONENT DR EL MRI
00802526559174	L301	ACCOLADE DR SL
00802526559181	L301	ACCOLADE DR SL
00802526572333	L301	ACCOLADE DR SL
00802526572340	L301	ACCOLADE DR SL
00802526576942	L301	ACCOLADE DR SL
00802526559228	L311	ACCOLADE DR SL MRI
00802526559235	L311	ACCOLADE DR SL MRI
00802526572395	L311	ACCOLADE DR SL MRI
00802526576461	L311	ACCOLADE DR SL MRI
00802526578076	L311	ACCOLADE DR SL MRI
00802526559242	L321	ACCOLADE DR EL
00802526559259	L321	ACCOLADE DR EL
00802526572425	L321	ACCOLADE DR EL
00802526593260	L321	ACCOLADE DR EL
00802526559266	L331	ACCOLADE DR EL MRI
00802526559273	L331	ACCOLADE DR EL MRI
00802526572456	L331	ACCOLADE DR EL MRI
00802526576485	L331	ACCOLADE DR EL MRI
00802526578083	L331	ACCOLADE DR EL MRI
00802526592201	L331	ACCOLADE DR EL MRI
00802526559358	S702	ALTRUA 2 DR SL
00802526572517	S702	ALTRUA 2 DR SL
00802526576508	S702	ALTRUA 2 DR SL
00802526577000	S702	ALTRUA 2 DR SL
00802526578106	S702	ALTRUA 2 DR SL
00802526593208	S702	ALTRUA 2 DR SL
00802526559365	S722	ALTRUA 2 DR EL
00802526559372	S722	ALTRUA 2 DR EL
00802526576515	S722	ALTRUA 2 DR EL
00802526577017	S722	ALTRUA 2 DR EL
00802526578113	S722	ALTRUA 2 DR EL
00802526593239	S722	ALTRUA 2 DR EL
00802526559389	U125	VALITUDE CRT-P EL
00802526559396	U125	VALITUDE CRT-P EL
00802526573101	U125	VALITUDE CRT-P EL
00802526573118	U125	VALITUDE CRT-P EL
00802526577024	U125	VALITUDE CRT-P EL
00802526577109	U125	VALITUDE CRT-P EL
00802526578793	U125	VALITUDE CRT-P EL
00802526559402	U128	VALITUDE CRT-P EL MRI
00802526559419	U128	VALITUDE CRT-P EL MRI
00802526572609	U128	VALITUDE CRT-P EL MRI
00802526572616	U128	VALITUDE CRT-P EL MRI
00802526576522	U128	VALITUDE CRT-P EL MRI
00802526577031	U128	VALITUDE CRT-P EL MRI
00802526578120	U128	VALITUDE CRT-P EL MRI
00802526593284	U128	VALITUDE CRT-P EL MRI
00802526559433	U225	VISIONIST CRT-P EL
00802526572630	U225	VISIONIST CRT-P EL
00802526577048	U225	VISIONIST CRT-P EL
00802526577116	U225	VISIONIST CRT-P EL
00802526578809	U225	VISIONIST CRT-P EL
00802526559457	U226	VISIONIST CRT-P EL
00802526559464	U226	VISIONIST CRT-P EL
00802526577062	U226	VISIONIST CRT-P EL
00802526577123	U226	VISIONIST CRT-P EL
00802526559488	U228	VISIONIST CRT-P EL MRI
00802526572692	U228	VISIONIST CRT-P EL MRI
00802526577130	U228	VISIONIST CRT-P EL MRI
00802526578830	U228	VISIONIST 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.