VersaCross Transseptal Sheath Kit (Boston Scientific) – Sterile Barrier Compromise (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
VXS0201 UDI-DI 00685447020301 Lot 35800622, VXS2112 UDI-DI 00685447019251 Lot 35892045
Products Sold
VXS0201 UDI-DI 00685447020301 Lot 35800622; VXS2112 UDI-DI 00685447019251 Lot 35892045
Boston Scientific Corporation is recalling VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VX due to Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026