BEUDAMED
    FDA Enforcement Class I Ongoing

    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

    Recall: Z-1484-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1484-2023
    Event ID
    91922
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cordis US Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2023
    Initiation Date
    March 24, 2023
    Classification Date
    May 11, 2023
    Address
    14201 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

    Reason

    There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.

    Code Info

    UDI/DI 20705032054802; Lot Numbers: 35264208, 35264212, 35265329, 35265654, 35265649, 35265667.

    Distribution

    Worldwide distribution.

    Quantity

    684 units