FDA
Food and Drug Administration · Recall Z-2751-2026 · Jun 11, 2026FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; 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 Pulsed Field Ablation Generator, Product ID M004PFCE61M401; 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 00191506042547Model Serial Numbers: 106247020.UPC 00191506042547Would 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.