BEUDAMED
    FDA Enforcement Class II Ongoing

    Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

    Recall: Z-1330-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1330-2025
    Event ID
    96272
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cordis US Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 19, 2025
    Initiation Date
    February 7, 2025
    Classification Date
    March 13, 2025
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802, United States

    Description

    Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

    Reason

    Catheter manufactured at the incorrect length.

    Code Info

    UDI: 20705032042991/ Lot Number: 18368326

    Distribution

    US: WA OUS: Japan

    Quantity

    12 units