Recall Z-2753-2026 ยท QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
| Date | Jul 17, 2026 (initiated Jun 11, 2026) |
| Status | Open, Classified |
| Reason | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall notice to its consignees out side the US on 6/11/2026 via hand delivered letter. The notice explained the issue and requested the following actions be taken: Instructions: 2- Allow Boston Scientific representative(s) to replace affected FARASTAR PFA generators. 3- Please complete the attached Verification Form even if you do not have any product to return and send it to your local Boston Scientific office 4- If you have products to return, please package them in an appropriate shipping box. After r |
| Quantity | 6 units |
| Distribution | International distribution in the countries of Italy, Austria, France, Germany, Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.