BEUDAMED
    FDA Enforcement Class II Ongoing

    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

    Recall: Z-1034-2025 · Reported February 5, 2025

    Enforcement

    Recall Number
    Z-1034-2025
    Event ID
    96049
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2025
    Initiation Date
    December 20, 2024
    Classification Date
    January 30, 2025
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States

    Description

    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

    Reason

    Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

    Code Info

    GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098

    Distribution

    Nationwide including Puerto Rico Foreign: To be provided

    Quantity

    519 units (OUS)