Boston Scientific Corporation recalls FARASTAR Ablation Generator EU
- Recalling company
- Boston Scientific Corporation
- Product
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Reason
- Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 11, 2026
- Reported
- Jul 29, 2026
- Distribution
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Status
- Ongoing
- Quantity
- 6 units
- Lot / codes
- GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
- Company location
- Saint Paul, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2753-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2753-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.