BEUDAMED
    FDA Recall Terminated

    myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.

    Recall: Z-0542-2020 · Initiated September 25, 2019

    Recall

    Recall Number
    Z-0542-2020
    Event Number
    83882
    Firm
    ENDOTRONIX
    FEI Number
    3013900541
    Product Code
    OUG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 25, 2019
    Terminated
    September 21, 2020
    Address
    815 Ogden Ave, Lisle, IL, 60532-1337

    Description

    myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.

    Reason

    The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

    Action

    The firm disseminated the notices by email on 09/25/2019 to the clinic level. The firm subsequently followed with telephone notices to the user level beginning on 10/16/2019 and posted a notice on their website.

    Distribution

    TX, IL, GA

    Quantity

    58 units