MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
FDA device recall Z-0509-2026 · posted 2025-11-14 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- 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.
- Action taken
- Medtronic Cardiac Surgery issued an Urgent: Medical Device Correction notice to its consignees on 10/03/2025. The notice explained the issue, potential harms, and requested the consignee contact Medtronic Sales Representative to schedule the service event to their affected VitalFlow" Console. Please reference Technical Service Update (TSU) "MOD0209" when scheduling. The notice also indicated that the consignees use unaffected VitalFlow Console devices, if available, until the correction has been completed. For questions regarding the communication, please contact your Medtronic Sales Representative.
- Root cause
- Software in the Use Environment
- Status
- Open, Classified
- Product code
- QNR
- Quantity affected
- 167 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-10-03
- Date posted
- 2025-11-14
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VitalFlow Console (K250199) | Medtronic, Inc. | 2025-05-20 |
| VitalFlow™ Console (K230364) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |