FDA Enforcement
Class II
Ongoing
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Recall: Z-2278-2025
·
Reported August 20, 2025
Enforcement
- Recall Number
- Z-2278-2025
- Event ID
- 97207
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 20, 2025
- Initiation Date
- June 25, 2025
- Classification Date
- August 8, 2025
- Address
- 4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States
Description
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
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 Info
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
US Nationwide.
Quantity
445 units