MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 03, 2025 |
| Reported | November 26, 2025 |
| Recalling firm | Medtronic Perfusion Systems |
| Country / region | United States MN |
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.
Affected products
- MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Related recalls
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