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

Recall date

October 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0509-2026

FDA classification

Class II

Brand / firm

Medtronic Perfusion Systems

Sold / distributed

US Nationwide distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo