Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
- Lot codes and dates
- GTIN 00191506043643
- Serial Numbers
106205893106450787107392777107476023108017345108521214108577158108695934109072152109484718109892816
- Amount recalled
- 11 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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