FDA-Device2025-11-26Class II
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
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.
Sold states
US Nationwide distribution.
Affected count
167 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief