BEUDAMED
    FDA Recall Open, Classified

    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

    Recall: Z-0509-2026 · Initiated October 3, 2025

    Recall

    Recall Number
    Z-0509-2026
    Event Number
    97806
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    QNR
    Status
    Open, Classified
    Root Cause
    Software in the Use Environment
    Initiated
    October 3, 2025
    Posted
    November 14, 2025
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

    Reason

    As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

    Action

    Medtronic Cardiac Surgery issued an Urgent: Medical Device Correction notice to its consignees on 10/03/2025. The notice explained the issue, potential harms, and requested the consignee contact Medtronic Sales Representative to schedule the service event to their affected VitalFlow" Console. Please reference Technical Service Update (TSU) "MOD0209" when scheduling. The notice also indicated that the consignees use unaffected VitalFlow Console devices, if available, until the correction has been completed. For questions regarding the communication, please contact your Medtronic Sales Representative.

    Distribution

    US Nationwide distribution.

    Quantity

    167 units