Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

FDA Recall Z-0509-2026 · Posted 2025-11-14

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeQNR
Date Initiated2025-10-03
Product Quantity167 units

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.

Firm Action

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

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K250199VitalFlow ConsoleMedtronic, Inc. · 2025-05-20K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑