BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 16, 2024

    Recall

    Recall Number
    Z-0962-2025
    Event Number
    95907
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    LQC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2024
    Posted
    January 16, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    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.

    Action

    Olympus notified consignees on 12/16/2024, via URGENT: MEDICAL DEVICE REMOVAL letter. Consignees were instructed to examine inventory for affected devices, cease usage of affected devices, and arrange for return of any affected devices. Consignees were also instructed to acknowledge receipt of the letter through Olympus online portal as well as to notify customers if the affected devices were further distributed.

    Distribution

    US Nationwide distribution.

    Quantity

    989 units