MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Reported: November 26, 2025 Initiated: October 3, 2025 #Z-0509-2026
Product Description
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.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 167 units
- Distribution
- US Nationwide distribution.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo. Recalled by Medtronic Perfusion Systems. Units affected: 167 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0509-2026.
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