FDA
Food and Drug Administration · Recall Z-2752-2026 · Jun 11, 2026FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Boston Scientific Corporation
The hazard
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
FARASTAR PFA Generator, Product ID M004PFCE61M460; 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 00191506043643Model Serial Numbers: 106205893Model 106450787Model 107392777Model 107476023Model 108017345Model 108521214Model 108577158Model 108695934Model 109072152Model 109484718Model 109892816.UPC 00191506043643Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.