Recall Z-2278-2025 ยท QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Boston Scientific Corporation
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
| Date | Aug 8, 2025 (initiated Jun 25, 2025) |
| Status | Open, Classified |
| 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 org |
| Quantity | 445 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.