The FDA announced on Oct. 3, 2025, that Medtronic Perfusion Systems is recalling MC3 VitalFlow Consoles due to an E70 error code causing temporary screen unresponsiveness. The agency classified the Class II recall as voluntary and initiated by the firm.
How to tell if you have it
- Brand: Medtronic
- Product: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
- UDI/DI: 10850007732247
- Units affected: 167
The hazard
As of Aug. 6, 2025, Medtronic 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. The console continues to maintain set pump speed and function throughout these events.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Integra C7000 Console Software Issue: Touch Screen Unresponsive (March 6, 2026), Fresenius Kabi Ivenix Infusion Pump Recall: Touchscreen Malfunction After Drops (May 6, 2026), and Medtronic MiniMed 780G Insulin Pump Recall: Software Error Causes Insulin Stoppage (May 27, 2026).