FDA recall Z-0509-2026

Medtronic Perfusion Systems · Class II · device

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-10-03
Report date
2025-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2026