Medtronic Perfusion Systems: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 167 units Lot/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.

UPC codes

10850007732247

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.