BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported July 16, 2025

    Enforcement

    Recall Number
    Z-2105-2025
    Event ID
    97036
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 16, 2025
    Initiation Date
    June 10, 2025
    Classification Date
    July 10, 2025
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    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.

    Code Info

    VXS0201 UDI-DI 00685447020301 Lot 35800622; VXS2112 UDI-DI 00685447019251 Lot 35892045

    Distribution

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

    Quantity

    14,724