Recall Z-2104-2025 ยท DXF Catheter, Septostomy
Boston Scientific Corporation
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
| Date | Jul 10, 2025 (initiated Jun 10, 2025) |
| Status | Open, Classified |
| Reason | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location. |
| Root cause | Packaging change control |
| Action | On June 10, 2025, the firm began notifying consignees of the field action via Urgent Medical Device Removal letters. Customers are instructed to not use affected product. They should remove affected units from their inventory and segregate the units in a secure place until they can be returned to Boston Scientific. |
| Quantity | 14,724 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.