FDAHealthJune 11, 2026

Boston Scientific Corporation — FARASTAR PFA Generator, Product ID M004PFCE61M460; 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 PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Brand: Boston Scientific Corporation
Lot code: GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.

Additional details

GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 11 units.

View original FDA notice →

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