Device product

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

Z-2278-2025

June 25, 2025

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 97207
Status: Ongoing
Classification: Class II
Quantity: 445 units
Official record key: device-enforcement:Z-2278-2025

Official wording

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.

Code information: UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578

Distribution pattern: US Nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.