BEUDAMED
    FDA Recall Open, Classified

    Coapt Dome Electrode, Gen2 system, cutaneous electrode

    Recall: Z-0203-2024 · Initiated October 2, 2023

    Recall

    Recall Number
    Z-0203-2024
    Event Number
    93137
    Firm
    Coapt LLC
    FEI Number
    3010605876
    Product Code
    GXY
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    October 2, 2023
    Posted
    October 31, 2023
    Address
    303 W Institute Pl, Ste 200, Chicago, IL, 60610-3080

    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.

    Action

    Coapt, LLC issued a Medical Device Correction notice to its consignees on 10/02/2023 via email. The notice explained the problem, risk, and urged users to take precautions as described in the most recent handbook: https://coaptengineering.com/clinicians. The handbook is under "Downloadable product handbooks."

    Distribution

    Worldwide distribution - US Nationwide and the country of Sweden.

    Quantity

    247 devices