FDA-Device2025-08-20Class II
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Hazard
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Sold states
US Nationwide.
Affected count
445 units
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2278-2025More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific TheraSphere 360 Y-90 software anomaly may cause incorrect dose calculations
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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