PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Reported: January 22, 2025 Initiated: December 12, 2024 #Z-0823-2025
Product Description
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
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? ▼
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).. 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-0823-2025.
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