Model note · ECMO

Medtronic VitalFlow ECMO System console

Name: Medtronic VitalFlow ECMO System console
Brand: VitalFlow

VitalFlow is Medtronic's dedicated ECMO platform, cleared in the US for long term (over 6 hours) ECMO pumping in adults with acute respiratory or cardiopulmonary failure. A touchscreen console drives a centrifugal pump through a motor drive that FDA notes is identical to the drive used with Medtronic's Bio-Console 560. An ultrasonic probe measures flow and can detect bubbles, and an emergency hand crank can drive the pump if the console or motor fails.

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The model

Maker, model and type.

Maker: Medtronic, Inc. (Medtronic Perfusion Systems; console originally from Michigan Critical Care Consultants, Inc., MC3)
Model: VitalFlow ECMO System console (REF 58100) with VitalFlow centrifugal pump and motor drive
Device type: ECMO
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
FDA classification	Blood pump for ECMO, long term (over 6 hours) use; 21 CFR 870.4100, Class II with special controls, product code QNR	Source
Clearances	K230364 VitalFlow Console (MC3), cleared 25 August 2023; K250199 upgrade over USB, decided 20 May 2025	Source
Maximum flow	7 L/min	Source
Maximum output pressure	680 mmHg at 3800 RPM	Source
Flow and bubble sensing	Clamp on ultrasonic transit time flow probe, with optional bubble detection	Source
Drive	DC motor drive with microprocessor based controller; drive motor identical to the reference Medtronic External Drive Motor 560A used with Bio-Console 560	Source
Backup drive	VitalFlow Emergency Handcrank to drive the pump manually if console or motor drive fails	Source
Data handling	Data download and streaming for circuit data only; no patient data stored; can display data from a compatible VitalFlow oxygenator	Source
Software update path	From K250199, field software upgrades over the USB port by Medtronic service only; older consoles needed each board (MC, SC, FPGA) updated with the case open	Source

Recalls

Known FDA recalls.

Z-0509-20262025-10-03
E70 error during normal use with the touch screen blank or unresponsive for up to two minutes.
FDA record

Safety

Safety warnings from the record.

The console is indicated only where other treatment options have failed and clinical deterioration or death is expected. Source
During an E70 event the operator may lose the touch screen for up to two minutes, so alarm awareness depends on other indicators. Source

Sources

Where this note comes from.

Not covered: VitalFlow is newer (2023 in the US) than most ECMO consoles, so its field history is short. Medtronic's brochure blocked automated access, so no facts are taken from it; battery run time, weight, speed range and electrical ratings are therefore missing. The instructions for use with the full alarm and error list were not found publicly; only E70 from an FDA recall is listed. MAUDE counts mix console and disposable reports. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

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