Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0509-2026 — MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

U.S. FDA — Device Enforcement · United States · 2025-10-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0509-2026
Date of alert
2025-10-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Perfusion Systems
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10850007732247
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.