United StatesThe MC3 VitalFlow Console (REF 58100), a blood pump for ECMO (UDI/DI 10850007732247) distributed nationwide in the US — 167 specific serial-numbered units — is being recalled. Medtronic reported eleven instances of the console displaying an E70 error code that can make the touchscreen temporarily unresponsive and go blank for up to two minutes during operation, although the console continues to maintain set pump speed and function.
What's being recalled
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN, United States.
How to identify it
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.
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)