Boston Scientific has expanded its recall of ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers to include all devices in the product family, the FDA announced. The agency classified this as a Class I recall, the most serious type that may cause serious injury or death without correction.

The recall affects 27 device models across the ACCOLADE family, including ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2, VALITUDE, and VISIONIST models. Boston Scientific sent an urgent medical device correction notice to affected customers on March 19.

The company is implementing Brady SMR6 software to address problems with the previous Brady SMR5 update. The earlier software had unintended behaviors including incomplete ZIP telemetry disablement and device misinterpretation of test results when magnets were present, which could lead to unintended telemetry disablement.

Boston Scientific has reported four deaths and 2,557 serious injuries associated with the issue as of March 18. The problems stem from high battery impedance that can cause devices to enter Safety Mode during telemetry procedures.

Healthcare providers must upgrade their LATITUDE Model 3300 programmers with Model 3869 v2.05 software, then upgrade pacemaker software by interrogating devices with the updated programmer. Patients at risk of harm from Safety Mode who have four or fewer years of device longevity remaining should be scheduled for prompt in-person follow-up.

The recall expands previous corrections issued in December 2024 and August 2025. Boston Scientific identified the battery impedance issue in late 2024, affecting a subpopulation of ACCOLADE devices that had increased potential to initiate Safety Mode during telemetry procedures.

The ACCOLADE family provides dual chamber bradycardia pacing and adaptive rate pacing to detect and treat slow heart rhythms. Boston Scientific is developing additional software updates to improve battery impedance test performance.