BEUDAMED
    FDA Recall Terminated

    CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000

    Recall: Z-2522-2018 · Initiated June 14, 2018

    Recall

    Recall Number
    Z-2522-2018
    Event Number
    80230
    Firm
    Abbott Laboratories, Inc.
    FEI Number
    3004936110
    Product Code
    MOM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 14, 2018
    Terminated
    September 8, 2021
    Address
    387 Technology Cir Nw, Ste 500, Atlanta, GA, 30313-2424

    Description

    CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000

    Reason

    Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.

    Action

    The firm notified the hospital and clinics of the recall on 06/14/2018 and the patients on 06/15/2018 by letter. The letter explained that the units may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics. The firm is requesting return of the units. Patients may contact Abbott Remote Care Technical Support at 1-844-692-6367 for assistance and further information.

    Distribution

    US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium

    Quantity

    2521 units