BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2105-2025 · Initiated June 10, 2025

    Recall

    Recall Number
    Z-2105-2025
    Event Number
    97036
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    DXF
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    June 10, 2025
    Posted
    July 10, 2025
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    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.

    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.

    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.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

    Quantity

    14,724