FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

FDA device recall Z-2278-2025 · posted 2025-08-08 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

QZI

Quantity affected

445 units

Distribution

US Nationwide.

Date initiated

2025-06-25

Date posted

2025-08-08

Location

Saint Paul, MN