Boston Scientific Corporation recalls FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Recall date
- June 25, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2278-2025
- FDA classification
- Class II
- Brand / firm
- Boston Scientific Corporation
- Sold / distributed
- US Nationwide.
Why it was recalled
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
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