BEUDAMED
    FDA Enforcement Class II Ongoing

    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

    Recall: Z-0509-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0509-2026
    Event ID
    97806
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2025
    Initiation Date
    October 3, 2025
    Classification Date
    November 14, 2025
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    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.

    Code Info

    UDI/DI 10850007732247, Serial Numbers: 000023, 000047, 000073, 000100, 000126, 000150, 000173, 000197, 000223, 000024, 000048, 000075, 000101, 000127, 000151, 000174, 000202, 000224, 000025, 000051, 000076, 000102, 000128, 000152, 000177, 000203, 000225, 000027, 000052, 000078, 000103, 000129, 000153, 000179, 000204, 000228, 000028, 000054, 000079, 000104, 000130, 000154, 000180, 000205, 000229, 000029, 000055, 000080, 000106, 000131, 000155, 000181, 000206, 000277, 000030, 000056, 000081, 000108, 000132, 000156, 000182, 000207, 000284, 000031, 000058, 000082, 000109, 000133, 000157, 000183, 000208, 000032, 000059, 000083, 000110, 000134, 000159, 000184, 000209, 000033, 000060, 000084, 000112, 000135, 000161, 000185, 000210, 000034, 000061, 000085, 000115, 000136, 000162, 000186, 000211, 000035, 000063, 000087, 000116, 000140, 000163, 000187, 000212, 000037, 000065, 000088, 000117, 000141, 000165, 000188, 000213, 000038, 000066, 000089, 000118, 000142, 000166, 000189, 000214, 000039, 000067, 000090, 000119, 000143, 000167, 000190, 000215, 000040, 000068, 000092, 000120, 000145, 000168, 000191, 000216, 000043, 000069, 000095, 000121, 000146, 000169, 000192, 000217, 000044, 000070, 000096, 000122, 000147, 000170, 000193, 000218, 000045, 000071, 000097, 000124, 000148, 000171, 000194, 000219, 000046, 000072, 000099, 000125, 000149, 000172, 000195, 000221.

    Distribution

    US Nationwide distribution.

    Quantity

    167 units