🔍 RecallPedia

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2025 Medtronic Perfusion Systems Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Perfusion Systems
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0509-2026

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