FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator recall
Boston Scientific Corporation recalled FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator on July 29, 2026 because of boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. It was sold in International distribution in the countries of Italy, Austria, France, Germany, Belgium..
Why it was recalled
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
What's recalled
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Quantity: 6 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 countries of Italy, Austria, France, Germany, Belgium.
- Status
- Ongoing
- Recall number
- Z-2753-2026
- Source
- U.S. Food and Drug Administration
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