Reported Nov 26, 2025 · Ongoing
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
MC3 VitalFlow ConsoleREF 58100Blood pump of ecmo
- Lot codes and dates
- UDI/DI 10850007732247
- Serial Numbers
167 of 167 codes
000023000047000073000100000126000150000173000197000223000024000048000075000101000127000151000174000202000224000025000051000076000102000128000152000177000203000225000027000052000078000103000129000153000179000204000228000028000054000079000104000130000154000180000205000229000029000055000080000106000131000155000181000206000277000030000056000081000108000132000156
- Amount recalled
- 167 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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