FDA-Device2025-01-22Class I
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Boston Scientific Corporation
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.
Sold states
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
Affected count
156,329 units (59,937 US, 96,792 OUS) in total
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2025Don't want to check this manually?
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