FDA
Food and Drug Administration · Recall Z-2750-2026 · Jun 11, 2026FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; 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 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 00810087180126Model Serial Numbers: 102174748Model 103355157Model 103432386Model 103480452Model 103547915Model 103836571Model 1-215-0040Model 1-226-0123Model 1-227-0129Model 1-228-0139Model 1-22C-0216Model 1-234-0276Model 1-237-0307Model 104015648Model 104993721Model 1-233-0266Model 1-236-0305Model 1-237-0307.UPC 00810087180126Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
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.