BEUDAMED
    FDA Recall Open, Classified

    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

    Recall: Z-0989-2025 · Initiated October 5, 2024

    Recall

    Recall Number
    Z-0989-2025
    Event Number
    95602
    Firm
    St. Jude Medical
    FEI Number
    3004936110
    Product Code
    MOM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 5, 2024
    Posted
    January 17, 2025
    Address
    387 Technology Cir Nw, Ste 500, Atlanta, GA, 30313-2424

    Description

    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

    Reason

    As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

    Action

    On 11/14-18/24, the firm sent an updated Notification informing customer that Abbott is recommending replacement of the affected Patient Electronics System (PES) that are resisting correction of their configuration file. On 12/13-16/2024, the firm sent an updated Notification for the Hospital Electronic Systems (HES) regarding inaccurate Pulmonary Artery (PA) reading. On October 15, 2024, Abbott initiated a database correction to return affected PES to their intended configuration files. After continued monitoring, Abbott has identified a subset of units that is resisting correction and is retaining their incorrect configuration file. To ensure impacted PES units return to transmission of accurate data, Abbott recommends that clinicians take the following actions: 1 Review the attached appendix which includes a complete listing of impacted patients PES systems. -Patients with a date listed have already successfully connected and resumed sending accurate data. This date corresponds to the return of accurate PA pressures being sent by the PES. From this date forward, the data may be used for patient management. -Patients without a date listed have not yet resumed sending accurate data. Please encourage patients to send daily data transmissions (PES readings) to ensure the correction can be initiated. 2 PA pressures taken between 9/30/2024 and the listed date on the attachment may still not be accurate even after the database correction and it is recommended not to use for patient management. For HES units, review the appendix to see patient sensors that have been impacted by the affected HES between September 30, 2024 and the HES correction date, and take action as recommended below: 1 If the HES was used to take a follow-up pressure reading it is recommended to ignore that reading for clinical decision making or patient management. 2 If the affected HES was used for implant or recalibration, please contact Abbott Rep or Remote Care Technical Support at 1-844

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada.

    Quantity

    431 units