CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 40-9551TRAK2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10815149020911), received between Mar 6, 2019 and Jun 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED, ¿WE HAD AN INCIDENT TODAY WHERE ONE OF OUR PATIENTS WITH A CORTRAK TUBE HAD HALF OF THE TUBE COME OUT OF HIS NOSE (THE BRIDLE WAS UNCLIPPED FOR REPOSITIONING) WHILE THE OTHER HALF REMAINED IN HIS STOMACH.¿ PER ADDITIONAL INFORMATION RECEIVED ON 23MAY2025, THE TUBE WAS IN PLACE FOR THREE WEEKS (PLACED ON 22APR2025). THE TUBE BREAK WAS FIRST IDENTIFIED ON 13MAY2025 VIA X-RAY. THERE WAS NO INJURY TO THE PATIENT. PATIENT REQUIRED ESOPHAGOGASTRODUODENOSCOPY TO RETRIEVE PORTION OF TUBE (APPROX. 100CM). THERE WAS A CLOG NOTED IN THE TUBE AND CLEARED ON 5MAY2025. NO PERMANENT HARM TO PATIENT. HE IS STILL ADMITTED BUT NOT FOR REASONS RELATED TO THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22150572 ↗
• MalfunctionMar 6, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE TUBE UPON INITIAL REPLACEMENT. THIS LED TO THE PATIENT DESATURATING. PER ADDITIONAL INFORMATION RECEIVED 27 FEB 2019, THE ISSUE WITH THE GUIDEWIRE PROLONGED THE PROCEDURE, AND THIS, ALONG WITH THE PATIENT'S UNDERLYING CONDITION, LED TO DESATURATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8397604 ↗
• MalfunctionMar 6, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE TUBE UPON INITIAL REPLACEMENT. THIS LED TO THE PATIENT DESATURATING. PER ADDITIONAL INFORMATION RECEIVED 27 FEB 2019, THE ISSUE WITH THE GUIDEWIRE PROLONGED THE PROCEDURE, AND THIS, ALONG WITH THE PATIENT'S UNDERLYING CONDITION, LED TO DESATURATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8394276 ↗