BEUDAMED
    FDA Enforcement Class II Ongoing

    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910

    Recall: Z-2231-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2231-2023
    Event ID
    92570
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 2, 2023
    Initiation Date
    May 25, 2023
    Classification Date
    July 21, 2023
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910

    Reason

    Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

    Code Info

    GTIN: 08714729978671 Lot Numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477 Exp. Date: 20-Oct-2025 to 10-Nov-2025

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    112 units