FDAHealthJune 25, 2025
Boston Scientific Corporation — FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
⚠️ The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 25, 2025
US Nationwide.
What's affected?
- Product
- FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Lot code
- UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
Additional details
UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 445 units.
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