BEUDAMED
    FDA Enforcement Class II Ongoing

    Coapt Dome Electrode, Gen2 system, cutaneous electrode

    Recall: Z-0203-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0203-2024
    Event ID
    93137
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Coapt LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 8, 2023
    Initiation Date
    October 2, 2023
    Classification Date
    October 31, 2023
    Address
    303 W Institute Pl Ste 200, N/A, Chicago, IL, 60610-3080, United States

    Description

    Coapt Dome Electrode, Gen2 system, cutaneous electrode

    Reason

    Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

    Code Info

    UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number

    Distribution

    Worldwide distribution - US Nationwide and the country of Sweden.

    Quantity

    247 devices