Boston Scientific Corporation: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Recall Summary Boston Scientific is recalling FARASTAR Pulsed Field Ablation Generator and related cardiac ablation catheters used to treat atrial fibrillation because the instruction manuals distributed with the devices were missing information about the FARAPOINT PFA catheter. The devices were distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland.
- Recalling firm
- 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 III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Distribution
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/849d5425-c8ca-4816-9c22-964bd3c4db07