United StatesFARASTAR Pulsed Field Ablation Generators (Product IDs 61M401, M004PFCE61M401, M004PFCE61M460) and associated percutaneous cardiac ablation catheters, identified by GTINs 00810087180126, 00191506042547, 00191506043643 and the listed serial numbers, were distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain and Ireland. They were recalled because the Instructions for Use provided with the devices did not include information for the FARAPOINT PFA catheter.
What's being recalled
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Recalling firm: Boston Scientific Corporation, Saint Paul, MN, United States.
How to identify it
GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307. GTIN 00191506042547, Serial Numbers: 106247020. GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.
The hazard
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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 states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
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