Boston Scientific Corporation recalls FARASTAR Pulsed Field Ablation Generator
- Recalling company
- Boston Scientific Corporation
- Product
- FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
- Reason
- Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- 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 states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- Status
- Ongoing
- Quantity
- 1 units
- Lot / codes
- GTIN 00191506042547, Serial Numbers: 106247020.
- Company location
- Saint Paul, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2751-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2751-2026 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.