FDA-Device2025-01-22Class I
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
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
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0822-2025Don't want to check this manually?
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