Boston Scientific Corporation 2026-07-29 Health serious FDA
Health · FDA · Recall #FDA-Z-2753-2026
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401;… Recall
Issued July 29, 2026 · Boston Scientific Corporation
In July 2026, Boston Scientific Corporation recalled the FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401;…, a serious 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 Dana Whitfield, RecallCheckr
What this means for you
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
What you should do
- 1 Stop using FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401;… 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
- July 29, 2026
- Units affected
- Not reported
- Sold at
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Recall number
- FDA-Z-2753-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 39 recalls in our database, including 13 rated Critical.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.