Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps

This recall involves correcting devices, and does not involve removing them from where they are used or sold. 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 correction.

Affected Product

The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all ACCOLADE pacemakers and CRT-Ps be corrected prior to continued use. Affected devices:

Product Name	Model Number	Device Listing	UDI-DI
ESSENTIO SR SL	L100	D114213	00802526558900
ESSENTIO DR SL Pacemaker	L101	D114213	00802526558924
ESSENTIO SR SL MRI Pacemaker	L110	D264942	00802526558948
ESSENTIO DR SL MRI Pacemaker	L111	D264942	00802526558962
ESSENTIO DR EL Pacemaker	L121*	D114213	00802526558986
ESSENTIO DR EL MRI Pacemaker	L131*	D264942	00802526559006
PROPONENT SR SL Pacemaker	L200	D114213	00802526559020
PROPONENT DR SL Pacemaker	L201	D114213	00802526559044
PROPONENT DR (VDD) SL Pacemaker	L209	OUS - No PMA	-
PROPONENT SR SL Pacemaker	L210	D264942	-
PROPONENT DR SL MRI Pacemaker	L211	D264942	-
PROPONENT DR EL Pacemaker	L221*	D114213	00802526559112
PROPONENT DR EL MRI Pacemaker	L231*	D264942	-
ACCOLADE SR SL Pacemaker	L300	D114213	00802526559150
ACCOLADE DR SL Pacemaker	L301	D114213	00802526559174
ACCOLADE SR SL MRI Pacemaker	L310	D264942	00802526559204
ACCOLADE DR SL MRI Pacemaker	L311	D264942	00802526559228
ACCOLADE DR EL Pacemaker	L321*	D114213	00802526559242
ACCOLADE DR EL MRI Pacemaker	L331*	D264942	00802526559266
ALTRUA 2 SR SL Pacemaker	S701	D114213	00802526559327
ALTRUA 2 DR SL Pacemaker	S702	D114213	00802526559341
ALTRUA 2 DR EL Pacemaker	S722*	D114213	00802526559365
VALITUDE CRT-P EL	U125*	D107733	00802526559389
VALITUDE CRT-P EL MRI	U128*	D107733	00802526559402
VISIONIST CRT-P EL	U225*	D107733	00802526559426
VISIONIST CRT-P EL	U226*	D107733	00802526559457
VISIONIST CRT-P EL MRI	U228*	D107733	00802526559471

All models listed should be upgraded to Brady SMR6. Models with an asterisk may have reduced longevity and have intensified follow-up recommendations.

To confirm if a device is affected, enter a model/serial number into the device lookup tool at www.BostonScientific.com/lookup.

What to Do

All ACCOLADE Family pacemakers and CRT-Ps should be upgraded to Brady SMR6 software according to the recommendations in the Product Advisory letter.

On March 19, Boston Scientific sent all affected customers an Urgent Medical Device Correction recommending the following actions:

Upgrade LATITUDE Model 3300 programmers with Model 3869 v2.05 software (Brady SMR6).
Upgrade pacemaker software in-clinic by interrogating the device with a programmer upgraded with Brady SMR6 (Model 3869 v2.05).
- Patients at risk of harm from Safety Mode who haven’t already received Brady SMR5: Promptly schedule an in-person follow-up if four or less years of longevity time remaining.
  - Note: The footer of the device follow-up report identifies the device firmware version. If the parenthetical at the end of the reported Firmware Version is “(3.10)” or greater, the device has been updated to either Brady SMR5 or SMR6.
- All other patients: Schedule the next in-person follow up at a frequency described in the Instructions for Use: every 12 months or every 3 months if the battery status reaches One-Year-Remaining.
Follow devices using the applicable flow chart found in Boston Scientific’s Urgent Medical Device Correction notice, based on the remote monitoring status (Figure 1 and 2).
There is a residual risk of in-clinic Safety Mode being induced by wanded telemetry. This risk applies to patients who are not monitored on the LATITUDE NXT Remote Patient Management System, are pacemaker dependent, and have a CRT-P or DR-EL device with three years or less longevity time remaining.
Update the medical record for each patient with an affected device by appending this letter to ensure continuous awareness throughout the device’s remaining service life.
Prophylactic replacement before confirming high battery impedance is not recommended.

Reason for Correction

Boston Scientific initiated this correction to expand the scope of the corrective action to include all ACCOLADE CRT-P and DR-EL devices and resolve unintended behaviors introduced with Brady SMR5. This expansion is due to the risk of early device replacement in CRT-P and DR-EL devices due to high battery impedance causing ZIP telemetry disablement.

Boston Scientific is implementing Brady SMR6, a software/firmware update intended to address unintended behaviors with the Brady SMR5 software. The Brady SMR6 software is installed on the Model 3300 LATITUDE programmer, and upon interrogation of any ACCOLADE Family pacemaker or CRT-P, the updated Model 3300 programmer will upgrade the device firmware with Brady SMR6. Brady SMR6 fully addresses the following SMR5 unintended behaviors:

ZIP Telemetry disablement was not complete for all telemetry scenarios, specifically RF wakeups.
The device misinterprets test results in the presence of a magnet, which led to unintended ZIP Telemetry disablement in some patients.
Boston Scientific identified, through internal investigation, a third potential behavior: prolonged voltage recovery state which may lead to a stuck battery status/diagnostics in some patients. There has not been a reported occurrence of this failure in fielded devices.

Brady SMR6 resolves the previously described incomplete ZIP disablement behavior and magnet-induced false positive battery impedance test. For remotely monitored patients, if ZIP becomes disabled due to high battery impedance, the device will post to the LATITUDE NXT “Patient Not Monitored” page after 14 days, rather than generating a “Remote Monitoring Disabled” alert.

This correction also expands the affected device scope to include all ACCOLADE CRT-P and DR-EL devices due to the potential that an individual device will need to be replaced early due to high battery impedance induced ZIP Telemetry disablement.

“Voltage Too Low for Remaining Battery Capacity” fault condition (FC1003) may be oversensitive in identifying devices that would have been at risk of ambulatory Safety Mode. To limit the number of premature explants due to FC1003, customized follow-up recommendations from Technical Services are available when FC1003 is observed.
There remains a risk of in-clinic Safety Mode being induced by wanded telemetry. This risk applies to patients not monitored on the LATITUDE Remote Patient Management System, who are pacemaker dependent, and who have a CRT-P or DR-EL device with three years or less longevity time remaining.

Boston Scientific is developing a software update and corresponding IFU revision to improve battery impedance test performance and address the longevity impact.

As of March 18, 2026, Boston Scientific has reported four deaths and 2557 serious injuries associated with this issue.

Background

Boston Scientific initiated this correction as a follow-up to previous recalls 97467 (August 2025) and 95969 (December 2024).

In late 2024, Boston Scientific identified a subpopulation of the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers with an increased potential to initiate Safety Mode during telemetry due to high battery impedance. The initial recall (95969) provided physicians with information about the subpopulation, failure mechanism, Safety Mode operation, and appropriate patient management recommendations for patients at risk of harm.

In August 2025, Boston Scientific launched a software/firmware update (“Brady SMR5”) as part of recall 97467. Brady SMR5 was designed to prevent the initiation of Safety Mode in an ambulatory setting due to high internal battery impedance. Brady SMR5 also added a test algorithm that can trigger the existing “Voltage Too Low for Remaining Battery Capacity” fault condition (FC1003), which directs the user to contact Boston Scientific Technical Services. Brady SMR5 was designed to disable wandless ZIP telemetry (ZIP) to prevent initiation of ambulatory Safety Mode if the device remains in service and the high battery impedance condition progresses to a specified threshold.

In September 2025, Boston Scientific sent an updated communication to customers outlining unintended behaviors identified with Brady SMR5 after launch, risk mitigations, and patient management recommendations.

Boston Scientific initiated this correction to resolve unintended behaviors introduced with Brady SMR5 and expand the scope of the corrective action to include all ACCOLADE CRT-P and DR-EL devices.

Device Use

The ACCOLADE family of implantable pacemakers provide dual chamber (atrial and ventricular) bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at tech.services@bsci.com or 1-800-227-3422.

Additional FDA Resources

FDA Enforcement Report
CDRH Medical Device Recall Database

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

Urgent Medical Device Correction Notice [03/2026]
Urgent Medical Device Correction Update [09/2025]
www.bostonscientific.com/ppr

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