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Boston Scientific Corporation recalls FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Recalled August 20, 2025 · FDA recall Z-2278-2025 · Boston Scientific
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. · FDA Class II
Units
445 units
Sold at
US Nationwide.
Description
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →