Class II
Medical Device Recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific Corporation · June 11, 2026
Reason for Recall
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Distribution
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
States Affected
IN
Quantity Affected
6 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2753-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.