MC3 VitalFlow Console — Class II medical device recall Z-0509-2026
Ongoing recall by Medtronic Perfusion Systems, reported 2025-11-26, distributed nationwide. As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code
| Recall number | Z-0509-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2025-10-03 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 167 units |
| UPC / GTIN / UDI-DI | 10850007732247 |
| Serial numbers | 000023, 000024, 000025, 000027, 000028, 000029, 000030, 000031, 000032, 000033, 000034, 000035, 000037, 000038, 000039, 000040, 000043, 000044, 000045, 000046, 000047, 000048, 000051, 000052, 000054 and 142 more |
| Model numbers | 58100 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0509-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.