Boston Scientific’s ACCOLADE family of implantable pacemakers provide dual chamber (atrial and ventricular) bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
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 a correction on May 2026 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, advising that all models listed in its March 19, 2026 Urgent Medical Device Correction should be upgraded to Brady SMR6 software according to the recommendations in the Product Advisory letter, and that models with an asterisk may have reduced longevity and have intensified follow-up recommendations.
On March 19, 2026 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.
- 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.
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 2,557 serious injuries associated with this issue.
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