Boston Scientific Corporation recalls PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221),…
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…
Read the official notice →- Date
- 2025-01-22
- Country
- United States
- Brand
- Boston Scientific
- Product
- PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL…
- Classification
- Class I
- Units
- US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign)…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon…
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FDA · DeviceBoston Scientific CorporationNationwide including Puerto Rico Foreign: To be providedOfficial notice → - 2024-12-04
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Other drugs & medical recalls in the United States
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Nuwellis Inc recalls nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex…
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Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;
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