—#214843

Product

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

FDA product code: QZI — Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P230030
Affected lot / 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

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: US Nationwide.

Timeline

Recall initiated: 2025-06-25
Posted by FDA: 2025-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.