BEUDAMED
    FDA Enforcement Class III Ongoing

    GreenLight HPSEA Laser Fibers, UPN 0010-2092

    Recall: Z-1392-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1392-2022
    Event ID
    90458
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    May 31, 2022
    Classification Date
    July 15, 2022
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    GreenLight HPSEA Laser Fibers, UPN 0010-2092

    Reason

    Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

    Code Info

    UDI-DI (GTIN): 00878953005522 Lot: 27770466

    Distribution

    Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.

    Quantity

    57