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Medtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Recalled November 26, 2025 · FDA recall Z-0509-2026 · Medtronic Perfusion Systems
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. · FDA Class II
Units
167 units
Sold at
US Nationwide distribution.
Description
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.
Product
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →