United StatesFARASTAR Ablation Generator EU (Pulsed Field Ablation Generator, Product ID 61M401) and associated Percutaneous Cardiac Ablation Catheter—GTIN/UDI 00810087180126, six units with serial numbers 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172—distributed in Italy, Austria, France, Germany and Belgium are affected. They were recalled because the FARASTAR PFA generators have a configuration that is not compatible for use with the FARAPOINT PFA catheter. Boston Scientific is replacing the specific affected generators.
What's being recalled
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Recalling firm: Boston Scientific Corporation, Saint Paul, MN, United States.
How to identify it
GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
The hazard
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada