FARASTAR Pulsed Field Ablation Generator recall
Boston Scientific Corporation recalled FARASTAR Pulsed Field Ablation Generator on July 29, 2026 because of labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. It was sold in International distribution in the states of Austria, Spain, France, Germany, Denmark, Ita….
Why it was recalled
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
What's recalled
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Quantity: 1 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Boston Scientific Corporation, Saint Paul, MN
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Ita…
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland. - Status
- Ongoing
- Recall number
- Z-2751-2026
- Source
- U.S. Food and Drug Administration
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