FDA-Device2025-01-22Class I
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
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
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0824-2025Don't want to check this manually?
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