BEUDAMED
    FDA Recall Terminated

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    Recall: Z-2334-2018 · Initiated April 16, 2018

    Recall

    Recall Number
    Z-2334-2018
    Event Number
    80244
    Firm
    St Jude Medical Inc.
    FEI Number
    2017865
    Product Code
    MXC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2018
    Terminated
    February 4, 2021
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    Reason

    The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

    Action

    The firm, Abbott, sent an "URGENT MEDICAL DEVICE CORRECTION" letters dated 05/18/2018, to its consignees notifying them that updated programmer software version 24.2.x will be made available over the next several weeks and will allow physicians to detect the presence of incorrect battery indicator prior to implant. Additionally, the programmer software will provide a mechanism to resolve the incorrect display for already implanted devices. If a low battery indicator is observed, customers were advised to contact firm technical services at 1-800-722-3774 to assist in confirmation and correction of the battery indicator display.

    Distribution

    U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,

    Quantity

    986