CORTRAK 2EAS 20-0950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815149024582), received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathOct 1, 2018Malposition of Device; Malposition of Device

  A MEDWATCH (MW) REPORT, FDA REPORT NUMBER FDA 3500 FORM (B)(4), WAS RECEIVED. IT WAS REPORTED THAT A FEEDING TUBE WAS PLACED USING THE CORTRAK 2 SYSTEM. WAVE FORM THE SAME AS WAVE PLACEMENT FROM 2 DAYS EARLIER. KIDNEY, URETER, AND BLADDER (KUB) X-RAY OBTAINED DUE TO CORTRAK BEING ONLY AT 45 MARK TO MAKE SURE IT WAS IN THE STOMACH. A DOCTOR TOLD BEDSIDE NURSE IT WAS OK TO USE. WHEN BEDSIDE NURSE WENT TO USE TUBE, THERE WAS A LARGE AMOUNT OF BLOOD COMING FROM THE TUBE. HAD SECRETARY CALL RADIOLOGY TO GET A STAT READING ON THE X-RAY. THE TUBE WAS REMOVED IN THE MEANTIME RADIOLOGY MD STATED THE TUBE WAS IN THE RIGHT LUNG. THE PT BEGAN TO DECLINE WITH DECREASING BLOOD OXYGEN SATURATION (SPO2) AND EVENTUALLY TO THE POINT A CODE BLUE WAS CALLED, DURING THE VERY LENGTHY CODE, THE HUSBAND WAS CALLED AND HE SAID TO STOP THE CODE THE CODE BLUE WAS STOPPED AND PT EXPIRED. ANOTHER DOCTOR WAS PRESENT FOR THE CODE. WHEN ASKED HE SAID NOT TO CALL THE MEDICAL EXAMINER AS IT WAS NOT NEEDED.

  Patient problems: Death; Low Oxygen Saturation

  MAUDE report 7924738 ↗