Recall Z-2278-2025— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2025-06-25. FDA's recall record names no specific 510(k) clearance for this event. Product: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401. Reason: The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-25
- Firm location
- Saint Paul, MN, United States
Product description
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.