FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Recall number
- Z-2278-2025
- Recalling firm
- Boston Scientific Corporation
- Product
- FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Status
- Open, Classified
- Initiated
- 2025-06-25
- Posted
- 2025-08-08
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 445 units
- Distribution
- US Nationwide.
- Lot, serial or model codes
- UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
- 510(k) numbers
- not on file
- PMA numbers
- ["P230030"]
- Product code
- QZI
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28