Cortrak 2 Enternal access device 46047Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00350770460475), received between Mar 16, 2021 and Jul 29, 2026 — classified as 2 deaths, 10 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072897 ↗
• MalfunctionJul 29, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072891 ↗
• MalfunctionJul 29, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072890 ↗
• MalfunctionJul 8, 2026Obstruction of Flow; Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 25749199 ↗
• MalfunctionJun 19, 2026Material Perforation

  IT WAS REPORTED THAT A CORTRAK TUBE WAS PERFORATED NEAR THE PORTS DURING USE, RESULTING IN REMOVAL AND REPLACEMENT OF THE TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565707 ↗
• MalfunctionJun 18, 2026Material Rupture

  IT WAS REPORTED, ONE OF THE FEEDING TUBES THAT WAS IN A PATIENT BURST. LOCATION OF BURST UNKNOWN AT THIS TIME. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552596 ↗
• MalfunctionJun 9, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A CORTRAK TUBE HAD A HOLE IN IT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443428 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22893750 THE FOLLOWING: REPORTS OF TUBE FEEDING [TF] FOUND LEAKING OUT OF HOLE IN ENTERAL TUBE BY RN. TF WAS FOUND LEAKING FROM NOSE DOWN THE TUBE ONTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156663 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED VIA MW REPORT (B)(4) THE FOLLOWING: THE NASOGASTRIC TUBE BURST WHEN FLUSHED. [LOCATION UNKNOWN]. ADDITIONAL INFORMATION RECEIVED 05-AUG-2024 STATED "NO PATIENT HARM, PATIENT HAS SINCE BEEN DISCHARGED. PATIENT HAD TO UNDERGO REINSERTION OF NEW TUBING." ADDITIONAL INFORMATION RECEIVED 09-AUG-2024 STATED "UNFORTUNATELY, THE REPORT IS NOT CLEAR ON WHERE THE BURST HAPPENED AND THERE ISN¿T DOCUMENTATION OF WHERE IT BURST IN THE PATIENT¿S CHART."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021877 ↗
• MalfunctionApr 22, 2026Break; Obstruction of Flow

  IT WAS REPORTED VIA FDA MEDWATCH /FDA USER FACILITY REPORT MW REPORT (B)(4) RECEIVED ON 10-OCT-2024, AND THE FOLLOWING INFORMATION WAS PROVIDED: "DESCRIBE THE EVENT OR PROBLEM: PATIENT'S NASOGASTRIC (NG) TUBE WAS CLOGGED. NURSE ATTEMPTED TO FLUSH AND ASPIRATE WITH WATER/DE-CLOGGING AGENTS. WHILE FLUSHING, THERE WAS A BREAK IN THE NG TUBE. THE NG TUBE WAS REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958627 ↗
• MalfunctionMar 10, 2026Stretched

  THE TUBE WAS FOUND TO HAVE BALLOONED OUTWARD DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 24563280 ↗
• MalfunctionMar 5, 2026Fracture

  IT WAS REPORTED THAT DURING USE OF THE CORTRAK NASOGASTRIC FEEDING TUBE, THE TUBE FRACTURED AT APPROXIMATELY THE LEVEL OF THE DIAPHRAGM, LEAVING A RETAINED SEGMENT IN THE PATIENT¿S STOMACH. THE REMAINING PORTION OF THE TUBE WAS REMOVED ENDOSCOPICALLY. ADDITIONAL INFORMATION RECEIVED ON 12-FEB-2026, REPORTING THAT THE TUBE HAD BEEN IN PLACE FOR NINE DAYS FOR FEEDING AND MEDICATION ADMINISTRATION, HAD BEEN PREVIOUSLY DECLOGGED ON (B)(6) 2026, AND RADIOLOGIC IMAGING (X-RAY) CONFIRMED A FRACTURE WITH A RETAINED SEGMENT IN THE GASTRIC BODY. NO COMORBIDITIES WERE IDENTIFIED, THE PATIENT WAS A 119-LB MALE, AND THE PATIENT WAS DISCHARGED FOLLOWING THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24521967 ↗
• MalfunctionMar 5, 2026Material Rupture

  IT WAS REPORTED THE CORTRAK TUBE RUPTURED WHILE INDWELLING IN THE PATIENT. THE DEVICE WAS IN USE FOR APPROXIMATELY 12-HOURS. THE PATIENT ASPIRATED. THE PATIENT WENT TO ENDOSCOPY TO HAVE TUBE THE PLACED ON (B)(6) 2025. THE PATIENT IS NOW DECEASED, BUT IT IS UNCERTAIN IF THE RUPTURED CORTRAK TUBE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION RECEIVED 26-FEB-2026 STATING "THE CORTRAK THAT HAS THE BALLOONING OUT IS NOT THE TUBE OF THE PATIENT THAT EXPIRED." THE NASOGASTRIC TUBE WAS OBSERVED TO HAVE BURST.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24520798 ↗
• MalfunctionFeb 13, 2026Material Rupture

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00059 FOR THE FIRST EVENT. IT WAS REPORTED THE CATHETER RUPTURED. THE REPORTER STATED, "I FEEL THESE ARE CLEAR CASES OF OPERATOR ERROR AND FORCE THROUGH KINK OR CLOG." ADDITIONAL INFORMATION RECEIVED NOTED THE DEVICE WAS IN PLACE FROM ON (B)(6) 2025 THROUGH ON (B)(6) 2026. THE BREAK WAS NOTICED ON REMOVAL. IT WAS DIFFICULT TO IDENTIFY WHERE THE BREAK OCCURRED. THE CLINICIAN NOTED "HARD TO TELL NUMBERS ARE BLURRY FROM DWELL, ON X-RAY KINK WAS PAST [GASTRO-ESOPHAGEAL JUNCTION] BUT NOT BY MUCH MAYBE 5-6 CM PAST. BALLOONING VISIBLE." THE RUPTURE OCCURRED INSIDE OF THE PATIENT. THE PATIENT WAS USING THE TUBE FOR CONTINUOUS FEEDINGS. THE DEVICE WAS USED FOR ORAL AND/OR CRUSHED MEDICATIONS. DOCUMENTATION SHOWS THE TUBE WAS FLUSHED APPROXIMATELY ON AVERAGE ONCE A DAY. THE DEVICE WAS FLUSHED MANUALLY. THERE WAS A HISTORY OF THE TUBE CLOGGING PRIOR TO THE RUPTURE. THE CLINICIANS USED CLOG ZAPPER TO TRY AND REMEDY THE CLOG. A NEW TUBE WAS PLACED AND FEEDINGS WERE CONTINUED. THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335268 ↗
• MalfunctionFeb 13, 2026Material Rupture

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00060 FOR THE SECOND EVENT. IT WAS REPORTED THE CATHETER RUPTURED. THE REPORTER STATED, "I FEEL THESE ARE CLEAR CASES OF OPERATOR ERROR AND FORCE THROUGH KINK OR CLOG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335153 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THE CORTRAK DUOTUBE BROKE OFF INSIDE A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328452 ↗
• InjuryJun 19, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THE "PATIENT HAD AN ATTEMPTED CORTRAK PLACEMENT BY THE IV (INTRAVENOUS) TEAM. FAILED TO ADVANCE THE TUBE BEYOND 12 CM. RD (REGISTERED DIETICIAN) TEAM CONSULTED, AND THEY ALSO FAILED TO ADVANCE TUBE BEYOND 20CM. ENT (EAR NOSE AND THROAT) GROUP CONSULTED, AND THEY ALSO FAILED TO ADVANCE THE FEEDING TUBE. GI (GASTROINTESTINAL) TEAM CONSULTED, AND THE TUBE WAS PLACED AT 70CM BUT THE CONFIRMATION IMAGING INDICATED THE TUBE TIP WAS IN THE DISTAL ESOPHAGUS. THE PRIMARY TEAM WAS INSTRUCTED BY THE GI TEAM TO PULL BACK THE TUBE TO RELEASE THE SUSPECTED COIL. THE TUBE WAS COMPLETELY REMOVED. EITHER THE IV TEAM OR THE RAPID RESPONSE TEAM AGAIN ATTEMPTED A TUBE PLACEMENT AT THE BEDSIDE. THE RN (REGISTERED NURSE) PLACING THE TUBE CHARTED SOMETHING TO THE EFFECT: THE TUBE WAS ADVANCED TO 50CM BUT FELT RESISTANCE LIKELY DUE TO THE PATIENTS KNOWN HIATAL HERNIA. THE FOLLOW-UP IMAGING REVEALED THE TUBE WAS IN THE PATIENT'S RIGHT LUNG WITH EVIDENCE OF A PNEUMOTHORAX. THE RN ALSO CHARTED THE PATIENT TOLERATED THE PROCEDURE WELL." THE CORTRAK TRACING WAS REVIEWED WITH THE RD AND IT WAS CONCLUDED THIS RN MADE SEVERAL ATTEMPTS (GREATER THAN SIX CORTRAK TRACINGS), EACH TIME THE TUBE WAS SEE

  Patient problems: Pneumothorax

  MAUDE report 22292752 ↗
• InjuryJun 6, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THE "NURSE PLACED CORTRAK TUBE INTO THE RIGHT LUNG WHICH LED TO A PNEUMOTHORAX CAUSING SUBCUTANEOUS EMPHYSEMA."

  Patient problems: Pneumothorax; Pulmonary Emphysema

  MAUDE report 22157548 ↗
• MalfunctionMay 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, ¿WE HAD A CORTRAK BREAK IN HALF IN A PATIENT THIS MORNING. THE NURSE NOTICED THAT THE PATIENT WAS GAGGING MORE. WHEN SHE LOOKED INTO THE BACK OF HER THROAT, SHE NOTED THAT THE NASOGASTRIC [NG] TUBE WAS SPLIT (STILL ATTACHED AT TIME). THE TEAM WAS ABLE TO SAFELY REMOVE BOTH HALVES OF THE NGT. ACCORDING TO THE REGISTERED NURSE [RN] AND PROVIDER AT BEDSIDE THERE WERE NO VISIBLE BITE MARKS ON THE TUBE, BUT THERE WAS A SINGLE LINEAR RIP. THE EVENTS LEADING UP TO THIS ARE A LITTLE UNCLEAR, AND I AM HOPING TO CLARIFY WITH THE RN TOMORROW MORNING. AS WE LOOKED INTO IT, THE STAFF STARTED TO STATE THAT THEY ARE CLOGGING FREQUENTLY.¿ THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Cough

  MAUDE report 22106257 ↗
• InjuryMar 27, 2025Malposition of Device; Malposition of Device

  IT WAS "REPORTED THE PATIENT SUFFERED A BOWEL PERFORATION THAT WAS DISCOVERED MORE THAN 1-DAY AFTER THE CORTRAK FEEDING TUBE WAS PLACED."

  Patient problems: Bowel Perforation

  MAUDE report 21706801 ↗
• MalfunctionMar 18, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED "A CORTRAK TUBE WAS PLACED WITH THE MACHINE AND FOUND TO HAVE CAUSED A PNEUMOTHORAX UPON INITIAL INSERTION." THE "HOSPITAL ATTRIBUTES [THE EVENT] TO USER ERROR."

  Patient problems: Pneumothorax

  MAUDE report 21635429 ↗
• MalfunctionDec 20, 2024Material Separation; Obstruction of Flow; Malposition of Device; Material Separation; Obstruction of Flow; Malposition of Device

  IT WAS REPORTED VIA FDA USER FACILITY REPORT NUMBER 360152-2024-0001 RECEIVED BY MAIL ON 21NOV2024, ¿CORETRAK FEEDING TUBE NOT WORKING PROPERLY. RESISTANCE UPON ATTEMPTING TO FLUSH. TUBE RETRACTED 5 CM WITH ATTEMPT TO FLUSH BUT STILL MEETING RESISTANCE. TUBE REMOVED, FOUND TO HAVE SEPARATION OF INTERNAL TUBING WITH EXTERNAL MEMBRANE STILL INTACT. PATIENT WAS LATER FOUND TO HAVE AN ESOPHAGEAL PERFORATION.¿ THE PATIENT DID REQUIRE ADDITIONAL TREATMENT AND TRANSFER TO A HIGHER LEVEL OF CARE.

  Patient problems: Perforation of Esophagus

  MAUDE report 20988363 ↗
• MalfunctionNov 27, 2024Partial Blockage; Material Puncture/Hole; Partial Blockage; Material Puncture/Hole

  IT WAS REPORTED THE [VATT REGISTERED NURSE] "RN WAS CONSULTED FOR A CLOGGED DOBHOFF TUBE. PATIENT HAD AN ORAL G-TUBE PRESENT. GOT X-RAY, [KIDNEY, URETER, AND BLADDER] KUB TIP OF FEEDING TUBE WAS IN THE DISTAL PYLORIC. NURSE TOOK OUT ORAL GASTRIC TUBE - COULDN'T FLUSH TUBE, SECOND X-RAY TAKEN ¿FEEDING TUBE WAS PULLED BACK TO THE LOCATION OF THE STOMACH. COULDN'T GET IT TO FLUSH. WENT BACK WITH WIRE TO PULL TUBE OUT SLOWLY, THE GUIDE WIRE PUNCTURED TUBE. ANOTHER KUB [KIDNEY, URETER, AND BLADDER] WAS USED AND EXTRA X-RAYS VERIFIED TUBING IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799649 ↗
• InjuryOct 31, 2024Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) THE FOLLOWING INFORMATION: "DATE OF EVENT: AUG-2024. THE NURSE WAS SUCTIONING THE PATIENT'S TRACHEOSTOMY AND NOTICED THAT THE CONTENTS LOOKED LIKE TUBE FEEDING. SHE NOTIFIED THE MEDICAL TEAM AND STOPPED THE TUBE FEEDS. THERE WAS CONCERN THAT THE TUBE MAY HAVE BROKEN APART INSIDE THE PATIENT, SO A X-RAY WITH CONTRAST WERE ORDERED TO INVESTIGATE. AROUND NOON THE X-RAY WITH CONTRAST CONFIRMED THAT THE FEEDING TUBE HAD IN FACT BROKEN INTO TWO PIECES INSIDE THE PATIENT. THE PART OF THE TUBE THAT WAS BRIDLED TO THE PATIENT'S NOSE WAS REMOVED AND IT IS BROKEN AT THE 31-CENTIMETER MARK, IMPLYING THAT THERE IS STILL A 30ISH CENTIMETER LONG PIECE OF THE TUBE INSIDE THE PATIENT'S STOMACH. GI HAS BEEN CONSULTED TO SCOPE THE PATIENT AND RETRIEVE THE OTHER PART OF THE TUBE. FEEDING TUBE REMOVED DURING UPPER GI ENDOSCOPY. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: TRACHEOSTOMY. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: COPD; MORBIDLY OBESE." ADDITIONAL INFORMATION RECEIVED 21-OCT-2024 "PATIENT DIED OF ACUTE RESPIRATORY FAILURE. THE DEATH WAS UNRELATED

  Patient problems: Foreign Body In Patient

  MAUDE report 20582171 ↗
• InjuryOct 22, 2024Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 13-DEC-2024 STATED THE, "PATIENT REQUIRED AN ADDITIONAL PROCEDURE BUT NO FURTHER COMPLICATIONS." TUBE PLACEMENT (B)(6)2024. THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) ON (B)(6) 2024 WHICH REVEALED THE CORPAK PASSING THROUGH THE GASTROESOPHAGEAL (GE) JUNCTION AND EXTENDING FROM THE CARDIA. THE FEEDING TUBE WAS REMOVED, AND THE ENTRY/EXIT SITES WERE CLOSED WITH A HEMOSTATIC PLACE TWO TIMES. "REPEAT IMAGING THEREAFTER DID NOT REVEAL ANY MEDIASTINAL FLUID COLLECTION OR LEAK." THE PATIENT'S INTAKE WAS ADVANCED SLOWLY UNTIL THE PATIENT WAS ABLE TO TOLERATE A REGULAR DIET WITHOUT ANY COMPLICATIONS. THE RADIOLOGIST IMAGING INTERPRETATION OF THE (B)(6) 2024 CHEST/ABDOMEN/PELVIS IMPRESSION COMPUTED TOMOGRAPHY (CT) NOTED "AXILLA, MEDIASTINUM, AND HILA: NO THORACIC LYMPHADENOPATHY. MILD RESIDUAL. PNEUMOMEDIASTINUM ABOUT THE LOWER ESOPHAGUS AND GE JUNCTION. SMALL HIATAL HERNIA. INTERVAL PLACEMENT OF LOWER ESOPHAGEAL ENDOLUMINAL CLIPS. INTERVAL REMOVAL OF ENTERIC FEEDING TUBE. NO PARAESOPHAGEAL FLUID COLLECTION."

  Patient problems: Pneumothorax

  MAUDE report 20507844 ↗