FARAWAVE Ablation Catheter (Boston Scientific) – Electrode Band Crack (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UDI-DI: 00191506043148
Products Sold
UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
Boston Scientific Corporation is recalling FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 due to The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Recommended Action
Per FDA guidance
An Urgent Medical Device Removal - Immediate Action Required notification letter dated June 2025 was sent to customers. Actions 1. Do NOT use affected product (Attachment 1), remove affected devices from your facility s inventory, segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page five. 5. Return affected product. Email: BSCFieldActionCenter@bsci.com Reach out to your local Boston Scientific representative with any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026