Boston Scientific Corporation: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Recall Summary Boston Scientific is recalling specific FARASTAR Pulsed Field Ablation (PFA) generators distributed in Italy, Austria, France, Germany, and Belgium because certain models are incompatible with the FARAPOINT PFA catheter used to treat atrial fibrillation. The incompatibility affects the proper functioning of the ablation system. This recall involves both the generator devices and associated catheters used in cardiac ablation procedures.
- Recalling firm
- 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 III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Distribution
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6e299e7c-345b-4928-9258-57c68ea2947e