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VitalFlow Console

MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Model 58100 · UDI-DI 10850007732247

QNR Prescription

510(k) clearances

397

Adverse events (13 deaths)

Recalls

Facilities

Description

Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for circuit data only; no patient data are stored or output.

Recalls

Date	Firm	Reason
2025-10-10	Thoratec LLC	Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failu
2025-10-03	Medtronic Perfusion Systems	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 becom

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.