BEUDAMED
    FDA Recall Open, Classified

    Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

    Recall: Z-0987-2025 · Initiated November 6, 2024

    Recall

    Recall Number
    Z-0987-2025
    Event Number
    95706
    Firm
    St. Jude Medical
    FEI Number
    3004936110
    Product Code
    MOM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 6, 2024
    Posted
    January 17, 2025
    Address
    387 Technology Cir Nw, Ste 500, Atlanta, GA, 30313-2424

    Description

    Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

    Reason

    Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

    Action

    On 11/06/2024, the firm sent an "URGENT: MEDICAL DEVICES CORRECTION", to customers to inform them that on September 30, 2024, the Merlin.net PCN HF Portal (MN6000) was migrated to the cloud database and following the migration, some customers reported that their Hospital Systems were unable to transmit to the Merlin.net PCN. User Action Requested: Abbott requests that clinicians take the following actions: The Impacted CM3100 Hospital System devices at your facility is/are listed in the enclosed Appendix. o For a Hospital System marked SESSIONS SENT no further correction is needed. o Hospital Systems marked UNSENT SESSIONS should be turned on to send unsent sessions: If your Hospital System has connectivity, it will immediately attempt to send after boot-up. A spinning icon will appear to indicate that transmission is in progress. If you see a button on the home screen showing X Unsent Sessions select the button and follow the prompts to send. If you are unable to send sessions, contact Abbott Remote Care Technical Support (RCTS) for assistance. Distribute this notice to appropriate personnel within your institution. Complete the included acknowledgment form and return it to Abbott. NOTE: Hospital Systems that were not used between September 30, 2024, and October 15, 2024, are not impacted. any questions about this notice or potential patient impact, please contact your Abbott representative or Remote Care Technical Support at 1-844-MYCMEMS (692-6367) Monday Friday, 5AM PST 5PM PST.

    Distribution

    U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A

    Quantity

    25 systems