Cortrak 2 Enternal access device 45818Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00350770458182), received between Jan 22, 2021 and Mar 30, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  PRIMARY REGISTERED NURSE (RN) PLACED A CORTRAK ENTERAL FEEDING TUBE INITIALLY WITHOUT ISSUE WITH TRACING CORRESPONDING TO GASTRIC PLACEMENT. THE RN WAS UNABLE TO ADVANCE THE TUBE FURTHER AND EXPERIENCED DIFFICULTY WITHDRAWING THE CORTRAK TUBE AND GUIDEWIRE. THE DEVICE WAS REMOVED AND WHEN THE GUIDEWIRE WAS REMOVED FROM THE TUBE IT WAS OBSERVED TO BE BENT. THE GUIDEWIRE WAS SEQUESTERED AND GIVEN TO UNIT LEADERSHIP. A SUBSEQUENT CORTRAK PLACEMENT ATTEMPT WAS SUCCESSFUL WITHOUT ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713977 ↗
• MalfunctionMar 24, 2026Material Rupture

  IT WAS REPORTED, ¿A PATIENT COMPLAINED OF PAIN AND THE TUBE HAD BURST OR BALLOONED OUT IN AN AREA.¿ PER ADDITIONAL INFORMATION RECEIVED ON 03-MAR-2026, PATIENT REPORTED THROAT DISCOMFORT DURING ENTERAL FEEDING INFUSION. THE REGISTERED NURSE (RN) FLUSHED THE TUBE AND THE PATIENT REPORTED INCREASED DISCOMFORT. THE FEEDING TUBE WAS REMOVED AND WAS FOUND TO HAVE ¿RUPTURED AT THE 38 MARKING.¿ THE DEVICE HAD BEEN IN PLACE FOR FOUR DAYS AND WAS USED FOR CONTINUOUS FEEDING AND ADMINISTRATION OF CRUSHED MEDICATIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FEEDING TUBE WAS NOT REPLACED AND THE PATIENT WAS STARTED ON A PUREED DIET. IT WAS ADDITIONALLY REPORTED, THERE WAS NO DIFFICULTY WITH THE INITIAL TUBE INSERTION. ONE PLACED, THE TUBE WAS FLUSHED PRIOR TO STYLET REMOVAL. THE TUBE WAS FLUSHED EVERY SIX HOURS WITH MEDS USING A 60CC SYRINGE. THERE IS NO HISTORY OF THE TUBE CLOGGING PRIOR TO THE BREAK.

  Patient problems: Discomfort

  MAUDE report 24675769 ↗
• MalfunctionFeb 17, 2026Flushing Problem; Stretched

  FDA MAUDE ADVERSE EVENT REPORT KEY (B)(4), "FEEDING TUBE THAT WAS IN PATIENT WAS NOT FUNCTIONING PROPERLY. IF WOULD NOT FLUSH. WHEN FEEDING TUBE PULLED ABOUT TO BE REPLACED, THE TUBE OBVIOUS DAMAGE - A 1.5 IN PORTION OF THE TUBE HAD BECOME A BALLOON AND WHEN FLUSHED THE FLUID WOULD FLUSH INTO THE BALLOON, THEN RETRACT BACKWARDS INTO THE SYRINGE."

  Patient problems: Insufficient Information

  MAUDE report 24367378 ↗
• InjurySep 19, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A GASTRIC BYPASS PATIENT EXPERIENCED A PERFORATION IN AN UNKNOWN LOCATION. AN OROGASTRIC (OG) TUBE WAS INITIALLY PLACED, THEN A CORTRAK NASOGASTRIC (NG) TUBE. THE FACILITY HIGHLY SUSPECTED THE OG TUBE CAUSED THE PERFORATION, AND THE CORTRAK TUBE FOLLOWED THE PATHWAY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Perforation

  MAUDE report 17777406 ↗
• InjuryNov 22, 2022Migration; Migration

  THE CLINICIAN REPORTED, THE CORTRAK TUBE HAD BEEN IN PLACE FOR 15 DAYS ON (B)(6) 2022 AND THE PATIENT WAS SCHEDULED NOTHING BY MOUTH (NPO) FOR THE OPERATING ROOM. WHEN TUBE FEEDING WAS RESTARTED, THAT AFTERNOON, THE PATIENT REPORTEDLY EXPERIENCED WORSENING RESPIRATORY STATUS WHICH PROMPTED A CHEST X-RAY FOR SHORTNESS OF BREATH. THE NURSE REPORTED THAT NO PRIOR ISSUES WERE NOTED WHEN FLUSHING THE TUBE; HOWEVER AT SOME POINT THE TUBE BECAME RETRACTED FROM THE D2 AREA WHERE IT COILED IN THE PATIENT¿S STOMACH. THE RADIOLOGIST REPORT READ AS ATTACHED. PER THE CLINICIAN, UPON REMOVAL OF THE TUBE, IT WAS FOUND TO BE IN TWO PIECES; THE PROXIMAL END OF THE TUBE WAS REMOVED, THE DISTAL END REMAINED IN THE PATIENT'S STOMACH. IT WAS REPORTED, THE PATIENT WILL BE REINTUBATED AFTER THE ENDOSCOPIC REMOVAL OF THE BROKEN TUBE. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED, THE TUBE WAS ORIGINALLY PLACED ON (B)(6) 2022 AT 9:00; THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AT 8:30PM ON (B)(6) 2022. A CHEST X-RAY WAS COMPLETED AND THE PHYSICIAN NOTIFIED THE REGISTERED NURSE (RN) THAT THE TUBE WAS EITHER KINKED OR PERFORATED; THE RN PULLED THE

  Patient problems: Foreign Body In Patient; Unspecified Respiratory Problem

  MAUDE report 15848845 ↗
• InjuryFeb 21, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT #MW 5106141. THE FOLLOWING INFORMATION WAS PROVIDED: RN ATTEMPTED TO PLACE A KEOFEED TUBE AT BEDSIDE. X-RAY CONFIRMATION FOR PLACEMENT SHOWED THAT THE TUBE PERFORATED THE LUNG AND CAUSED A LEFT SIDED PNEUMOTHORAX. WHICH REQUIRED A CHEST TUBE FOR TREATMENT.

  Patient problems: Internal Organ Perforation; Pneumothorax

  MAUDE report 13572937 ↗
• InjuryDec 29, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT (B)(4) THE FOLLOWING INFORMATION: AFTER THE CORTRAK WAS INSERTED THE PATIENT DEVELOPED SYMPTOMS OF SMALL BOW OBSTRUCTION; AN X-RAY WAS PERFORMED AND THE TUBE APPEARED ROTATED AND SEVERED ON FILM. IT WAS NOTED THE TUBE WAS EXTRACTED 10 CM AND THE X-RAY WAS REPEATED, GASROVUE WAS INJECTED AND THE AREA OF RUPTURE WAS CONFIRMED; A GI CONSULT WAS OBTAINED FOR REMOVAL. ADDITIONALLY, IT WAS REPORTED THAT THE TUBE HAD TO BE UNCLOGGED USING A WARM WATER FLUSH AND SOME MANUAL PRESSURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13114127 ↗
• InjuryDec 7, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED A NURSE "GRABBED A CORTRAK TUBE AND PLACED WITHOUT THE CORTRAK MACHINE AKA 'BLIND.' THE HOSPITAL WAS AWARE THAT CORTRAK WASN'T USED. THE 'BLIND' PLACEMENT CAUSED A PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 12956898 ↗
• MalfunctionJan 22, 2021Burst Container or Vessel; Fracture; Material Rupture; Burst Container or Vessel; Fracture; Material Rupture

  IT WAS REPORTED THAT THE TUBE WAS BLOCKED AT THE GASTRO-ESOPHAGEAL JUNCTION. THE TUBE WAS WITHDRAWN SLIGHTLY, THE MOVEMENT OF WHICH THEN CAUSED THE TUBE TO "COMPLETELY DISCONNECT AND 40CM OF TUBE WAS REMOVED FROM THE PATIENT." THE USER FACILITY REPORTED THAT UPON LOOKING AT THE EXTERNAL 40CM OF TUBE, "IT'S CLEAR EXCESS PRESSURE HAS BEEN GIVEN IN AN ATTEMPT TO UNBLOCK THE TUBE, CAUSING THE TUBE TO ANEURYSM, RUPTURING AND SEVERING THE TUBE IN TWO. 80CM OF TUBE REMAINS INSIDE THE PATIENT." A CT [COMPUTED TOMOGRAPHY] SCAN WAS PERFORMED, WHICH IDENTIFIED THE TUBE WAS STILL IN THE PATIENT'S STOMACH WITH THE DISTAL TIP WITHIN THE JEJUNUM. ADDITIONAL INFORMATION RECEIVED 11-JAN-2021 INDICATED THE PATIENT WAS NO LONGER IN INTENSIVE CARE AND WAS RECOVERING FROM COVID. THERE WAS AN EPISODE OF VOMITING AND ABDOMINAL DISTENTION; A CT SCAN SHOWED NO OBSTRUCTION AND THE TUBE WAS STILL IN THE GI [GASTROINTESTINAL] TRACT (ONE END IN FUNDUS, OTHER IN JEJUNUM). THE PATIENT HAD NOT YET PASSED THE TUBE NATURALLY. THE USER FACILITY STATED THEY WERE WAITING TO SEE IF AN ENDOSCOPY WOULD BE REQUIRED TO REMOVE THE REMAINING TUBE AND "NIL HARM TO DATE HAS BEEN CAUSED."

  Patient problems: Abdominal Distention; Foreign Body In Patient; Vomiting

  MAUDE report 11218293 ↗