FDAHealthJune 11, 2026
Boston Scientific Corporation — FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
⚠️ Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2026
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
What's affected?
- Product
- FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
- Lot code
- GTIN 00191506042547, Serial Numbers: 106247020.
Additional details
GTIN 00191506042547, Serial Numbers: 106247020.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 units.
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