Z-2278-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- June 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 445 units
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.
Distribution Pattern
US Nationwide.
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