FDA-Device2025-08-20Class II
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Boston Scientific Corporation
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-2278-2025Don't want to check this manually?
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