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Boston Scientific Corporation recalls ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Recalled January 22, 2025 · FDA recall Z-0825-2025 · Boston Scientific
Hazard
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance. · FDA Class I
Units
156,329 units (59,937 US, 96,792 OUS) in total
Sold at
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
Description
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →