Recall Z-0509-2026— Medtronic Perfusion Systems

Name: FDA recall Z-0509-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-03

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2025-10-03. It names 2 FDA 510(k) clearances: K250199, K230364. Product: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo. Reason: 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..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2025-10-03
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K250199 — VitalFlow ConsoleMedtronic, Inc.·cleared 2025-05-20
K230364 — VitalFlow ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)·cleared 2023-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.