Cortrak 2 Enternal access device 46100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770461007), received between Apr 28, 2023 and May 23, 2025 — classified as 1 injury, 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 16, 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.

• MalfunctionMay 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE "NUTRITION NURSE INSERTED CORTRAK TUBE INTO THE BOWEL, REMOVED STYLET AND THEN RE-INSERTED TUBE FOR A RE-TRACE WHICH IS STANDARD PRACTICE WHEN USING CORTRAK AT THIS TRUST. SHE FELT SOME RESISTANCE ON RE-INSERTION ¿ ¿WE¿VE UNFORTUNATELY HAD AN ISSUE TODAY WITH AN NJT [NASO-JEJUNAL TUBE] BEING PERFORATED BY THE STYLET. THE TUBE WAS PLACED WHAT WAS THOUGHT TO BE SUCCESSFULLY, THE WIRE WAS REMOVED WITH NO STIFFNESS AT ALL BUT WHEN THE WIRE WAS PLACED BACK INTO THE TUBE TO GET THE FINAL TRACE, THERE WAS A SLIGHT BIT OF RESISTANCE, WITH SLIGHT PRESSURE, THE WIRE THEN PASSED EASILY. THE TRACE SHOWED THAT THE TUBE WAS KINKED SO IT WAS WITHDRAWN INTO THE OESOPHAGUS AND THE TUBE PASSED WITH EASE. HOWEVER, THE PATIENT STARTED COMPLAINT OF PAIN AND A BURNING SENSATION, SO WE REMOVED THE TUBE AND THE NJT HAD BEEN PERFORATED BY THE WIRE." THERE WAS NO REPORTED INJURY.

  Patient problems: Burning Sensation; Pain

  MAUDE report 22081888 ↗
• MalfunctionApr 11, 2025Break; Break

  IT WAS REPORTED, ¿THE NJ [NASOJEJUNAL] WAS INSERTED ON THE (B)(6). NJ PLACEMENT WAS CORRECT ON CXR [CHEST X-RAY] TODAY POST PYLORUS. THIS PM [NIGHT] IT HAS BEEN NOTED THAT THE NJ VERY UNUSUALLY SNAPPED IN HALF AT THE BACK OF THE PATIENTS THROAT. APPEARS TO HAVE MELTED APART.¿ PER ADDITIONAL INFORMATION RECEIVED ON 20MAR2025, ¿THIS PATIENT REQUIRED PROCEDURAL SEDATION AND ANESTHETIC SUPPORT TO SAFELY RETRIEVE (USING MAGILL FORCEPS) THE LOWER ASPECT OF THE NJT TUBE. THE PROCEDURE WAS SUCCESSFUL, AND THE FULL TUBING WAS REMOVED. HOWEVER, THIS COULD HAVE BEEN A SERIOUS RISK TO THE PATIENT HAD IT NOT HAVE BEEN PROMPTLY RECTIFIED. AS THE LOWER PART OF THE TUBING MAY HAVE TRANSITIONED FURTHER INTO THE PATIENT CAUSING SIGNIFICANT RISK WHICH MAY HAVE WARRANTED URGENT ENDOSCOPIC REMOVAL. THIS WAS A CRITICAL INCIDENT WHICH WAS MANAGED EFFECTIVELY. NO OVERT INJURY OCCURRED AS THE PATIENT HAD A CUFFED TRACHEOSTOMY INSITU AT THE TIME THEREFORE DID NOT ASPIRATE ANY ORAL ENTERAL FEED INTO THE LUNGS. PATIENT REMAINS CRITICALLY UNWELL- BUT UNCHANGED CLINICAL STATUS.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 21830530 ↗
• InjuryApr 28, 2023Break; Break

  IT WAS REPORTED THAT A PORTION OF THE NASOGASTRIC TUBE (NGT) WAS MISSING AND WAS RETAINED IN THE PATIENT. A CHEST X-RAY WAS PERFORMED, ON (B)(6) 2023, AND NOTED THE NGT WAS STILL HIGH UP IN THE OESOPHAGUS; THE CONSULTANT PERFORMED A LARYNGOSCOPY AND WAS ABLE TO REMOVE IT WITH MACGILLS FORCEPS. THE CURRENT STATUS OF THE PATIENT WAS REPORTED TO BE UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16833181 ↗