Official recall record
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-10-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10850007732247
- Brand on record
- Medtronic Perfusion Systems
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
All 5 official recall notices naming Medtronic Perfusion Systems on this site →
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