MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Pending LLM rewrite. Source: FDA_DEVICE Z-0509-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 10850007732247
- Serial Numbers: 000023
- 000047
- 000073
- 000100
- 000126
- 000150
- 000173
- 000197
- 000223
- 000024
- 000048
- 000075
- 000101
- 000127
- 000151
- 000174
- 000202
- 000224
- 000025
Distribution
Distributed nationwide across the United States.
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