ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Reported: January 22, 2025 Initiated: December 12, 2024 #Z-0824-2025
Product Description
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 156,329 units (59,937 US, 96,792 OUS) in total
- Distribution
- US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131). Recalled by Boston Scientific Corporation. Units affected: 156,329 units (59,937 US, 96,792 OUS) in total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Critical. Recall number: Z-0824-2025.
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