ECMO consoles recalled after eleven reports of a blank touchscreen error
Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an unresponsive console interface during ECMO blocks operator control, and no injuries are reported.
Plain-English summary
The MC3 VitalFlow Console, REF 58100, a blood pump console used for ECMO, from Medtronic Perfusion Systems, is being recalled.
As of 6 August 2025 Medtronic had 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. Medtronic states the console continues to maintain set pump speed and function throughout.
The recall covers 167 units carrying UDI/DI 10850007732247, distributed nationwide in the United States. The FDA has classified the action as Class II.
An unresponsive interface means an operator cannot adjust or read the console during that window, even though pump output continues. The enforcement record reports no injuries. Facilities operating an affected console should follow Medtronic's instructions.
The recalled product
- Product
- MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 167
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.
Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05