Cortrak 2 Enternal access device 46098Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00350770460987), received between Apr 13, 2021 and Apr 30, 2026 — classified as 1 death, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00262 FOR THE FIRST REPORT. IT WAS REPORTED THAT A NASOJEJUNAL TUBE HAS KINKED AT 38-40CMS ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043695 ↗
• MalfunctionMar 10, 2026Material Twisted/Bent

  IT WAS REPORTED, THE PATIENT HAD A CORFLO NJ 10FR NASOJEJUNAL (NJ) TUBE IN PLACE FOR DELIVERY OF FEEDS AND MEDICATIONS. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER THE TUBE HAD BEEN REMOVED. A REPLACEMENT 10FR NJ TUBE WAS INSERTED AT THE BEDSIDE, AND THE PATIENT WAS DISCHARGED. THE FOLLOWING DAY, THE PATIENT RETURNED DUE TO A BLOCKED NJ TUBE. IMAGING DEMONSTRATED A KINK, AND THE TUBE REMAINED OCCLUDED DESPITE ATTEMPTS TO RETRACT IT. ON THE NEXT CLINICAL REVIEW, THE TUBE WAS REMOVED, AND A VISIBLE KINK WAS NOTED APPROXIMATELY 4 CM FROM THE DISTAL TIP. A NEW 10FR NJ TUBE WAS SUBSEQUENTLY INSERTED USING CORTRAK GUIDANCE, AND THE PATIENT WAS DISCHARGED. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY EIGHT MONTHS. NO PATIENT INJURY OCCURRED, AND NO MEDICAL TREATMENT WAS REQUIRED BEYOND TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562476 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THE "PATIENT ATTENDED THE GASTROENTEROLOGY DAY UNIT TODAY FOR [NASOJEJUNAL] NJ REPLACEMENT. PATIENT'S NJT HAD BEEN BLOCKED/KINKED 2 WEEKS AGO, NOW FELT TO BE IN [THE PATIENT'S] STOMACH. [ANTERIOR X-RAY] AXR DEMONSTRATED THAT THE TUBE WAS IN [THE PATIENT'S] STOMACH. ON REMOVAL OF THE TUBE (10FR CORFLO NJ), ONLY HALF THE TUBE CAME OUT (60CMS) MEANING THERE IS 80CMS OF TUBE LEFT IN [THE PATIENT'S] STOMACH. IT LOOKS LIKE THE TUBE HAS BALLOONED AND SPLIT, AS IF THERE HAS BEEN ATTEMPTS MADE TO UNBLOCK THE TUBE" AND THE PATIENT REPORTS DID NOT ATTEMPT TO UNBLOCK THE TUBE. "NEW NJ PLACED BY [INTERVENTIONAL RADIOLOGY] IR. ARRANGED REPEAT AXR FOR 3-DAYS TO ENSURE TUBE HAS PASSED. BOWEL OBSTRUCTION ADVICE / SAFETY NET ADVICE GIVEN." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24199509 ↗
• InjuryNov 21, 2025Material Puncture/Hole; Malposition of Device; Material Puncture/Hole; Malposition of Device

  IT WAS REPORTED THAT DURING PLACEMENT OF A NASOJEJUNAL (NJ) TUBE, THE GUIDEWIRE PERFORATED THE TUBE AND CAUSED TRAUMA TO THE ESOPHAGUS OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 03-NOV-2025. STATED WHILE THE CLINICIAN WAS INSERTING THE NJ TUBE ON AN INTENSIVE CARE UNIT (ICU) PATIENT, "LARGE FUNDAL COIL NOTED ON SCREEN, SLOWLY PULLED WIRE AND TUBE BACK UNTIL COIL REMOVED. ON RE-INSERTING WIRE INTO TUBE, THE WIRE MOVED UNUSUALLY AND VERY SUDDENLY FORWARD. "[THE CLINICIAN]" INSTANTLY REMOVED THE TUBE FROM THE PATIENT AND FOUND 10+CM OF ELECTROMAGNETIC WIRE HAS PERFORATED THE TUBE. THE TUBE WAS LIKELY PERFORATED WHILST IN THE PATIENT'S ESOPHAGUS (35CM) ."[THE CLINICIAN]" STOPPED THE PROCEDURE AND SPOKE WITH THE ICU CONSULTANT IMMEDIATELY.PATIENT HAD LOCALIZED BLEEDING, THE NG WAS ASPIRATED, AND IT WAS BLOOD STAINED/BLOOD CONTAINING."

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 23625002 ↗
• DeathApr 3, 2025Break; Malposition of Device; Break; Malposition of Device

  IT WAS REPORTED THE NASO-JEJUNAL (NJ) TUBE WAS PLACED WITH THE NEW MAGNETIC DEVICE. THE CAREGIVERS WERE "CONCERNED AS THE TUBE BECAME STIFF VERY QUICKLY." THE PATIENT ENDED UP HAVING A REPLACEMENT ON (B)(6) 2025 WHICH WAS "ONLY AROUND 3-MONTHS LATER." MOREOVER, WHEN INTERVENTIONAL RADIOLOGIST (IR) WENT TO REPLACE IT, THE TUBE HAD RUPTURED, AND A SEGMENT HAD BROKEN OFF AND WAS LODGED IN THE DUODENUM MAKING IT DIFFICULT FOR A FURTHER NJ TO BE SITED BY IR. THE PATIENT WAS "NOT FIT ENOUGH FOR [A] OGD [OESOPHAGO-GASTRO-DUODENOSCOPY] TO REMOVE IT." THE PATIENT "DIED SHORTLY AFTER THE PROCEDURE FROM ASPIRATION PNEUMONIA. IT WAS NOTED THE PATIENT WAS "ADMITTED WITH AN UGI [UPPER GASTROINTESTINAL] BLEED."

  Patient problems: Foreign Body In Patient

  MAUDE report 21762911 ↗
• MalfunctionOct 16, 2024Break; Material Puncture/Hole; Obstruction of Flow; Break; Material Puncture/Hole; Obstruction of Flow

  IT WAS REPORTED, "THERE HAS BEEN AN INCIDENT LATELY WITH ONE OF YOUR PRODUCTS, NJ [NASOJEJUNAL] TUBE 10FR 140CM. NJ TUBE BROKE OFF / SNAPPED ON THE (B)(6) 2024. AFTER RETURNING FROM THEATRE I PLANNED IN REMOVING THE NJ TUBE AS PER PLAN BECAUSE IT WAS HANDED OVER THAT IT WAS BLOCKED. ALSO, THE MEDICAL TEAM WAS AWARE OF IT AND ADVISED TO REMOVE IT. WHEN I REMOVED THE NJ, I NOTICED THAT PART OF IT WAS MISSING (IT SNAPPED AT 62CM AND APPROXIMATELY 57CM REMAINED INSIDE). I CALLED THE SPR [SPECIALIST REGISTRAR] ON DUTY AND IMMEDIATELY INFORMED THEM ABOUT WHAT HAPPENED. ADVISED TO KEEP THE PATIENT NBM [NOTHING BY MOUTH] AND WAIT FOR THE X-RAY TO CONFIRM THE POSITION OF THE TUBE (THE ONE LEFT INSIDE). THE MEDICAL TEAM WILL CONTACT THE GASTRO-TEAM FOR ADVICE TO MANAGE THIS ISSUE. X-RAY HAS BEEN DONE AND TIP OF NJ TUBE IS VISIBLE IN STOMACH. GASTRO CAME TO REVIEW AND DID A RETRIEVAL OF NJ TUBE REMNANT (REMOVED ENDOSCOPICALLY) ON THE (B)(6) 2024. THE NJ TUBE REMNANT WAS FOUND TO HAVE A HOLE AND SOMEWHAT TORN.¿ PER ADDITIONAL INFORMATION RECEIVED ON 26SEP2024, THE PATIENT DID NOT SUSTAIN ANY INJURIES AND IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20465958 ↗
• MalfunctionOct 6, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE COTRAK10FR NASOGASTRIC (NJT) TUBE WAS INSERTED ON (B)(6) 2022, FOR AN INTENSIVE CARE UNIT (ICU) PATIENT; IT WAS USED FOR FEEDING. MEDICAL NOTES REPORTED, ON (B)(6) 2022, SPIKED PYREXIA 39.7 FOR BLOOD CULTURES, COMPUTED TOMOGRAPHY (CT) CHEST X-RAY (CXR); ¿HUGE AMOUNTS OF DIRTY OFFENSIVE SMELL SUBGLOTTIC SECRETIONS¿ WERE NOTED; ADDITIONALLY, [THE PATIENT] REPORTEDLY DESATURATED AT CT TO 73%. THE CXR WAS REVIEWED, NJT COULD BE FOLLOWED TO DISTAL RADIUS BUT NO FURTHER AND LOOPS OF NJT COULD BE SEEN IN THE PATIENT¿S STOMACH. AN ATTEMPT TO ASPIRATE THE PATIENT WAS UNSUCCESSFUL, AN ATTEMPT TO FLUSH THE TUBE WAS ALSO UNSUCCESSFUL; THE DECISION WAS MADE TO REMOVE THE TUBE. DURING REMOVAL THE MEDICAL DOCTOR (MD) MET SOME RESISTANCE BUT EVENTUALLY REMOVED THE TUBE AND FOUND IT TO BE FRACTURED AT 80CM (65CM REMAINED IN THE STOMACH/DUODENUM/JEJUNUM). A CT WAS TAKEN AND THE [REMAINING] TRACHEOSTOMY TUBE WAS SEEN IN THE ESOPHAGUS WITH FRACTURED DISTAL SEGMENT COMPLETELY DETACHED FROM IT, EXTENDING FROM THE DISTAL PART OF STOMACH INTO THE JEJUNUM. THE PATIENT¿S ESOPHAGUS WAS DILATED IN ITS ENTIRE EXTENT WITH AIR AND RESIDUAL FEED WITHIN. A GENERAL SURGEON WAS CONSULTED WHO ADV

  Patient problems: Foreign Body In Patient

  MAUDE report 15553946 ↗
• MalfunctionApr 13, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FEEDING TUBE WAS COMPLETELY SPLIT AT APPROXIMATELY THE 72CM MARKING. THIS WAS CONFIRMED BY A CT SCAN. THE LOWER PART OF THE FEEDING TUBE REMAINS IN THE PATIENT'S JEJUNUM AND THE USER FACILITY HAS ADVISED TO WAIT FOR IT TO PASS NATURALLY. THE PATIENT IS RECEIVING REGULAR ABDOMINAL X-RAYS TO CHECK THE LOCATION OF THE RETAINED TUBE. NO PATIENT INJURY WAS REPORTED. A NEW TUBE WAS INSERTED TO DECOMPRESS THE STOMACH. THE PRODUCT WAS IN USE FOR 22 DAYS. ADDITIONAL INFORMATION RECEIVED 06-APR-2021 INDICATED THE "SEPARATION OF THE TUBE WAS BELOW THE ESOPHAGUS."

  Patient problems: Foreign Body In Patient

  MAUDE report 11660832 ↗