BEUDAMED
    FDA Enforcement Class II Ongoing

    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.

    Recall: Z-0962-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0962-2025
    Event ID
    95907
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 16, 2024
    Classification Date
    January 16, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.

    Reason

    Potential for distal tip tearing of the Mechanical Lithotriptor V.

    Code Info

    UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K

    Distribution

    US Nationwide distribution.

    Quantity

    989 units