CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9368TRAK2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815149023882), received between Oct 20, 2017 and Oct 20, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2017Break; Break

  IT WAS REPORTED VIA FDA MAUDE REPORT KEY (B)(4): "CORTRAK BROKE UPON REMOVAL, LEAVING TUBING BEHIND THAT HAD TO BE REMOVED BY GI PROCEDURES." THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6965538 ↗
• MalfunctionOct 20, 2017Break; Break

  IT WAS REPORTED VIA FDA MAUDE REPORT KEY (B)(4): "ELDERLY FEMALE ADMITTED TO BURN UNIT FOR 23% TOTAL BODY SURFACE AREA (TBSA) BURN. CORTRAK PLACED ABOUT THREE WEEKS LATER AND REMOVED ABOUT A MONTH AFTER INSERTION WHEN IT WAS NOTED THAT THE PATIENT HAD TUBE FEEDS COMING OUT OF HER MOUTH WHEN MEDICATIONS WERE ADMINISTERED THROUGH THE ADJACENT NG TUBE. THE CORTRAK BROKE OFF AT THE 20 CM MARK. THE EXISTING TIP OF THE TUBE APPEARS TO BE RUPTURED. APPROXIMATELY 20 CM OF THE END OF THE CORTRAK WAS RETAINED IN THE STOMACH. IT WAS SUCCESSFULLY REMOVED ON THE SAME DAY VIA BEDSIDE EGD."

  Patient problems: No Code Available

  MAUDE report 6965536 ↗