Recall Z-2105-2025 ยท DXF Catheter, Septostomy
Boston Scientific Corporation
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
| 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
| K183655 | VersaCross Transseptal Sheath Baylis Medical Company, Inc., May 20, 2019 |