FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific Corporation
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model GTIN/UDI 00810087180126Model Serial Numbers: 1-217-0053Model 1-21C-0078Model 1-223-0099Model 1-225-0106Model 1-225-0107Model 1-229-0172.UPC 00810087180126Would you have heard about this one?
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