Class II
Medical Device Recall: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Boston Scientific Corporation · June 25, 2025
Reason for Recall
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Distribution
US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
445 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2278-2025
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.