Medical Device Recall: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Medtronic Perfusion Systems · October 3, 2025
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.
States Affected
NATIONWIDE
Quantity Affected
167 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0509-2026
Status: ongoing
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