Medical Device Recall: 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 · December 12, 2024
Reason for Recall
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.
Distribution
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
States Affected
NATIONWIDE
Quantity Affected
156,329 units (59,937 US, 96,792 OUS) in total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0824-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.