FARAWAVE 1.0 Pulsed Field Ablation Catheter recall
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Why was FARAWAVE 1.0 Pulsed Field Ablation Catheter recalled?
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
- Product
- FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 445 units
- Distribution
- US Nationwide.
- Recall date
- August 20, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)