Boston Scientific Corporation 2025-01-22 Health critical FDA
Health · FDA · Recall #FDA-Z-0823-2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI… Recall
Issued January 22, 2025 · Boston Scientific Corporation
In January 2025, Boston Scientific Corporation recalled the PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- January 22, 2025
- Units affected
- Not reported
- Sold at
- US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
- Recall number
- FDA-Z-0823-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.