Medtronic Perfusion Systems: Medical Device Recall in 2025 - (Recall #: Z-0509-2026)
See the recall detail below. You can also see other recalls from the same firm in 2025.
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Class II
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.
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.
US Nationwide distribution.
Voluntary: Firm initiated
