CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00350770472010), received between Aug 22, 2019 and Sep 21, 2026 — classified as 22 deaths, 107 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (119 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 21, 2022Class ITerminated

   Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

   Z-1032-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Malposition of Device

  Patient problems: Pneumothorax

  MAUDE report 50846517 ↗
• InjurySep 21, 2026Malposition of Device

  Avanos Medical Inc. received a single report that referenced different incidents, which were associated with separate units, involving different patients. This is the third of three reports.Refer to 3011270181-2026-00177 for the first report.Refer to 3011270181-2026-00178 for the second report .Refer to 3011270181-2026-00179 for the third report .It was reported that a nasogastric feeding tube was placed in the patient's lung. It is unknown whether the placement was performed using the CORTRAK 2 Enteral Access System or by blind placement. No patient injury, medical intervention, or additional procedural or outcome information was provided.

  Patient problems: Insufficient Information

  MAUDE report 50844229 ↗
• InjurySep 21, 2026Malposition of Device

  Patient problems: Pneumothorax

  MAUDE report 50844218 ↗
• InjurySep 21, 2026Malposition of Device

  Patient problems: Insufficient Information

  MAUDE report 50844213 ↗
• DeathSep 21, 2026Malposition of Device

  It was reported that during use of a CORTRAK 2 Enteral Access System, lung placement and a pneumothorax occurred. It was further reported that the patient died. The relationship between the reported event and the patient's death is unknown.

  Patient problems: Pneumothorax

  MAUDE report 50844183 ↗
• InjuryMay 28, 2026Difficult or Delayed Positioning; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO FOR THE FIRST REPORT REFER TO 3011270181-2026-00075 FOR THE SECOND REPORT . THE CUSTOMER REPORTED THAT DURING PLACEMENT OF A CORTRAK FEEDING TUBE, THE MONITOR TRACING REPORTEDLY LAGGED DURING PLACEMENT. THE TUBE APPEARED TO BE LOCATED IN THE LEFT UPPER QUADRANT; HOWEVER, SUBSEQUENT KIDNEY, URETER, AND BLADDER (KUB) IMAGING REPORTEDLY IDENTIFIED THE TUBE IN THE UPPER LEFT LUNG LOBE. THE PLACEMENT REPORTEDLY RESULTED IN A PNEUMOTHORAX. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 25322498 ↗
• InjuryMay 28, 2026Difficult or Delayed Positioning; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2026-00074 FOR THE FIRST REPORT REFER TO FOR THE SECOND REPORT. THE CUSTOMER REPORTED THAT DURING PLACEMENT OF A CORTRAK FEEDING TUBE, THE MONITOR TRACING REPORTEDLY LAGGED DURING PLACEMENT. THE TUBE APPEARED TO BE LOCATED IN THE LEFT UPPER QUADRANT; HOWEVER, SUBSEQUENT KIDNEY, URETER, AND BLADDER (KUB) IMAGING REPORTEDLY IDENTIFIED THE TUBE IN THE UPPER LEFT LUNG LOBE. THE PLACEMENT REPORTEDLY RESULTED IN A PNEUMOTHORAX. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 25322497 ↗
• InjuryJul 17, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED, "THERE WAS A LUNG PLACEMENT USING THE CORTRAK¿ THE PATIENT HAD A PNEUMOTHORAX AND REQUIRED A CHEST TUBE.¿

  Patient problems: Pneumothorax

  MAUDE report 22529389 ↗
• InjuryJul 9, 2025Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2025-00024 FOR THE SECOND REPORT. IT WAS REPORTED, LUNG PLACEMENT WITH CORTRAK UNIT. ¿PATIENT HAD A CORTRAK PLACED BY AN EXPERIENCED SUPER USER. THE PATIENT DID NOT SHOW ANY SIGNS OF DISTRESS DURING THE PROCEDURE. FOLLOW UP THE NEXT DAY ((B)(6) 2025), PATIENT STARTED TO COMPLAIN ABOUT UPPER QUADRANT ABDOMINAL PAIN. KIDNEY, URETER, AND BLADDER (KUB) AND CHEST XRAY DONE, SHOWED A NEW HEMOTHORAX. PATIENT REQUIRED A TRANSFER TO HIGHER LEVEL OF CARE AND CHEST TUBE INSERTION TO TREAT. NO DEATH, CURRENTLY STABLE STILL IN THE HOSPITAL.¿ PATIENT WAS NOT INTUBATED AT TIME OF PLACEMENT, NO ATYPICAL ANATOMY REPORTED. THE INCIDENT DISCOVERED DUE TO PATIENT BECOMING SYMPTOMATIC.

  Patient problems: Hemothorax; Pain; Pneumothorax

  MAUDE report 22461991 ↗
• InjuryJul 9, 2025Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2025-00023 FOR THE FIRST REPORT IT WAS REPORTED, LUNG PLACEMENT WITH CORTRAK UNIT. ¿THE PATIENT WAS ALERT AND ORIENTED AND SHOWED NO SIGNS OF COUGHING/ SHORTNESS OF BREATH (SOB) UNTIL OXYGEN SATURATIONS STARTED TO DROP. THE TWO TRAINED CORTRAK RNS STATED AFTER THE PROCEDURE THAT THEY WERE HAVING DIFFICULTY WITH THE DEVICE. THEY STATED THAT EVERY TIME THEY TRIED TO ADVANCE THE TUBE, THE GREEN DOT WOULD NOT MOVE. THE GREEN DOT STAYED POSITIONED AT THE TOP OF THE SCREEN "BOUNCING" AS IF IT WAS COILING IN THE THROAT. THEY PULLED BACK AND ATTEMPTED TO ADVANCE SEVERAL TIMES, AS THE TUBE DID NOT EVER APPEAR TO MOVE. WHEN THE TUBE TRACING DID MOVE, IT MOVED VERY QUICKLY, NOT IN ASSOCIATION WITH THEIR "ADVANCING" AND APPEARED BOTH TIMES, SPONTANEOUSLY IN WHAT APPEARED TO BE THE LOWER LUNG. THEY REMOVED THE TUBE BOTH TIMES AND CALLED FOR ASSISTANCE. THE PATIENT DEVELOPED A PNEUMOTHORAX AND NEEDED A CHEST TUBE. THE PATIENT DID RECOVER. NO DEATH. DISCHARGED TO REHAB. CORTRAK 2 E

  Patient problems: Hypoxia; Pneumothorax

  MAUDE report 22461976 ↗
• InjuryApr 3, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED "THERE WAS A POSSIBLE PERFORATED ESOPHAGUS INTO PLEURA." A KUB [(KIDNEY, URETER, AND BLADDER) WAS TAKEN PRIOR TO FEED INITIATION, FEEDS WERE INITIATED AND A CHEST DRAIN HAD TO BE PLACED." ADDITIONAL INFORMATION RECEIVED 20-MAR-2025 STATING THE PATIENT HAD CORTRAK INSERTED. A KUB WAS PERFORMED TO VERIFY PLACEMENT. "THE PATIENT WAS TRANSFERRED TO A TELEMETRY FLOOR. OVERNIGHT THE PATIENT HAD INCREASED [OXYGEN] O2 NEEDS. ON (B)(6) 2025, THE CHEST X-RAY REVEALED THE CORTRAK WAS IN THE LUNG. THE PATIENT RECEIVED TUBE FEED IN THE HOURS PRIOR TO THE DISCOVERY. THE PATIENT ULTIMATELY REQUIRED INTUBATION. A FOLLOW UP CHEST X-RAY SHOWED A PNEUMOTHORAX, AND A CHEST TUBE WAS INSERTED. THE PATIENT REMAINED INTUBATED AND SEDATED UNTIL A COMPASSIONATE WEAN DECISION WAS MADE BY THE FAMILY." ADDITIONAL INFORMATION RECEIVED 21-MAR-2025 STATING THE DATE OF EXPIRATION IS UNKNOWN "AS THE PATIENT WAS TRANSFERRED TO HOSPICE ON [(B)(6) 2025]."

  Patient problems: Low Oxygen Saturation; Pneumothorax

  MAUDE report 21766046 ↗
• InjuryFeb 27, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT WAS "ADMITTED TO HOSPITAL (B)(6) 2025." THE PATIENT WAS ON TEN LITERS OF OXYGEN (02) VIA FACE MASK AT THE TIME OF FEEDING TUBE PLACEMENT. THE CORTRAK TUBE PLACEMENT ATTEMPT WAS PERFORMED ON (B)(6) 2025. PER HOSPITAL POLICY A CARBON DIOXIDE (CO2) DETECTOR WAS USED DURING PLACEMENT. THE "FIRST ATTEMPT, TRACING WITH TIME STAMP 15:09, REGISTERED NURSE (RN) "REPORTS CO2 DETECTOR SHOWED COLOR CHANGE INDICATING TUBE WAS IN THE LUNG, "[PATIENT]" ALSO COUGHING DURING FIRST ATTEMPT AND TUBE WAS REMOVED. ANTERIOR VIEW SHOWS TUBE TIP DEVIATION TO THE RIGHT IN THE UPPER QUADRANT." THE "SECOND TRACING, TIME 15:12, DURATION 43 SECONDS. RN USED A NEW CO2 DETECTOR FOR THIS PLACEMENT. "[COMMUNICATION WITH]" TO RN WHO REPORTS "[PATIENT]" DID NOT COUGH, STATS WERE STABLE, NO DROP IN OXYGEN (SPO2), CO2 DETECTOR DID NOT HAVE COLOR CHANGE TO INDICATE TUBE WAS IN THE LUNG. ANTERIOR VIEW SHOWS TUBE DEVIATES TO THE RIGHT. RN STATES SHE WAS CONCERNED WITH THE TRACING ON THE ANTERIOR VIEW, HOWEVER, THE CO2 DETECTOR DID NOT INDICATE SHE WAS IN THE LUNG AND "[PATIENT]" DID NOT HAVE ANY OTHER SIGNS AND SYMPTOMS TO INDICATE SHE WAS IN THE LUNG AND ASSUMED THE RECEIVER WAS NOT IN THE CO

  Patient problems: Cough; Pneumothorax

  MAUDE report 21479442 ↗
• InjuryFeb 27, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THE REGISTERED NURSE (RN) REPORTED PLACING A FEEDING TUBE IN A SIMILARLY CONFUSED PATIENT A WHILE BACK AND EVEN THOUGH THE RN SUSPECTED THE RECEIVER UNIT MOVED DURING THE PLACEMENT PROCEDURE. THE RN THOUGHT IT WAS GOOD ENOUGH. THE RN NOTED HAVING A DECENT TRACING AND FELT LIKE IT WAS A GOOD GASTRIC PLACEMENT BUT UPON X-RAY CONFIRMATION, IT WAS NOTED THAT THE FEEDING TUBE WAS IN THE LUNG AND CAUSED A PNEUMOTHORAX. THE RN ACKNOWLEDGED TAPING THE RECEIVER UNIT TO THE PATIENT'S GOWN. THE RN DID NOT UTILIZE THE LATERAL VIEW AND DEPTH CROSS SECTION VIEWS. IT IS NOT KNOWN WHEN THIS INCIDENT OCCURRED, AND THERE ARE NO STORED TRACING FILES ON THE DEVICE...IT IS ALSO NOT KNOWN IF THE PATIENT SUFFERED ANY OTHER HARM AS A RESULT OF THE PNEUMOTHORAX. ADDITIONAL INFORMATION RECEIVED 19-FEB-2025 STATING THE DEVICE [SOFTWARE] WAS NOT UPDATED TO 2.8 UNTIL 28-JAN-2025. THE CORTRAK WAS RUNNING ON AN OLDER SOFTWARE VERSION AT THE TIME OF THE INCIDENT; THE EXACT SOFTWARE VERSION IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 21478662 ↗
• InjuryNov 7, 2024Malposition of Device; Malposition of Device

  PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, THE PATIENT HAS SINCE BEEN DISCHARGED HOME. THE HOSPITAL CONFIRMS TUBE PLACEMENT BY X-RAY. THE USER OF THE DEVICE WAS A TRAINED OPERATOR.

  Patient problems: Pneumothorax

  MAUDE report 20629204 ↗
• InjuryAug 14, 2024Inadequate or Insufficient Training; Malposition of Device; Inadequate or Insufficient Training; Malposition of Device

  IT WAS REPORTED, A LUNG PUNCTURED OCCURRED WITH CORTRAK EAS. POTENTIAL CONTRIBUTING FACTORS OF "UNCERTIFIED USER."

  Patient problems: Pneumothorax

  MAUDE report 19983325 ↗
• InjuryAug 13, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, A LUNG PUNCTURE IN THE LAST 60 DAYS WHEN THE CORTRAK WAS BEING USED. POTENTIAL CONTRIBUTING FACTOR BEING DISPLACEMENT OF STYLET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 19977279 ↗
• InjuryAug 6, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, NURSE IS AWARE OF ONE PNEUMOTHORAX THAT OCCURRED WITH CORTRAK. POTENTIAL CONTRIBUTING FACTOR INCLUDE ¿THRASHING PATIENTS.¿

  Patient problems: Pneumothorax

  MAUDE report 19919911 ↗
• InjuryJul 25, 2024Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED, PATIENT HAD A CORTRAK TUBE PLACEMENT THAT RESULTED IN A PNEUMOTHORAX. UPON INSPECTION OF CORTRAK PLACEMENT, SR. DIRECTOR OF CRITICAL CARE SERVICES INDICATED THAT THE PLACEMENT SHOWED A DEVIATION INTO THE RIGHT LUNG. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2024, PATIENT RECEIVED A CHEST TUBE.

  Patient problems: Pneumothorax

  MAUDE report 19829571 ↗
• InjuryJul 15, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, LUNG PUNCTURE OCCURRED WITHIN THE LAST 90 DAYS USING CORTRAK EAS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 19740320 ↗
• InjuryJun 19, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, REGISTERED DIETITIANS (RD) REPORTED A NIGHT SHIFT NURSE PLACED A CORTRAK TUBE USING THE CORTRAK MACHINE INTO PATIENT'S RIGHT LUNG; TUBE PLACED TO 98 CM. PATIENT IS A RECENT BILATERAL LUNG TRANSPLANT; PER RDS THERE WAS SOME DAMAGE TO LOWER LOBE, BUT NOT PNEUMOTHORAX AND THEY BELIEVE PATIENT IS FINE. THE FOLLOWING MORNING, DIETITIANS SUCCESSFULLY PLACED A NEW CORTRAK TUBE INTO THE DUODENUM WITH NO COMPLICATIONS. DIETITIANS REVIEWED CORTRAK LUNG TRACING AND STATED NIGHT SHIFT NURSE SPENT APPROXIMATELY 8 MINUTES PLACING TUBE AND THE TUBE WAS OBVIOUSLY IN A LUNG PER DIETITIANS. PER ADDITIONAL INFORMATION RECEIVED ON 05JUN2024, THE INCIDENT WAS DISCOVERED FOLLOWING X-RAY CONFIRMATION. THE TUBE WAS REMOVED AND REPLACED THE FOLLOWING MORNING.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 19567293 ↗
• InjuryJun 17, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, ¿INCORRECT INSERTION INTO LUNG OCCURRED. VERY SMALL AMOUNT OF NUTRITION WAS MIS-ADMINISTERED INTO LUNG. THE MONITOR SHOWED THE INCORRECT INSERTION, BUT IT WAS NOT NOTICED DURING THE INSERTION AND ALSO FROM X-RAY DATA AFTER INSERTION.¿ NO MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19553911 ↗
• InjuryJun 17, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, WITHIN THE LAST 90 DAYS, A PNEUMOTHORAX OCCURRED WHILE USING CORTRAK 2. POTENTIAL CONTRIBUTING FACTOR WAS REPORTED AS ¿LONGER STAY.¿ THE TYPICAL PLACEMENT CONFIRMATION METHOD FOR THE FACILITY IS X-RAY.

  Patient problems: Pneumothorax

  MAUDE report 19546573 ↗
• InjuryJun 14, 2024Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  PER ADDITIONAL INFORMATION RECEIVED ON 17JUN2024, THE PATIENT¿S CAUSE OF DEATH WAS ¿HYPERCAPNIA, HEART FAILURE.¿

  Patient problems: Pneumothorax

  MAUDE report 19538502 ↗
• InjuryJun 4, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, ¿ON SITE FOR CORTRAK TRAINING. PERFORMED AUDIT OF MACHINES TO SEE WHAT TUBES HAD BEEN PLACED OVER THE WEEKEND WHEN AVANOS CLINICIAN WAS NOT AVAILABLE FOR BEDSIDE COACHING. FOUND A TRACING THAT WAS CONCERNING FOR LATE START AND RECEIVER MISPOSITIONED. DISCUSSED WITH CLINICIAN ON SITE WHO SUBSEQUENTLY PULLED THE CORRESPONDING ABDOMINAL FILM SHOWING THE TUBE TIP IN THE PATIENTS R LUNG. TUBE MISPOSITIONED IN THE R PULMONARY SPACE PER RADIOLOGIST READ. F/U CHEST CT NEGATIVE FOR PNEUMOTHORAX. THE PATIENT WAS STILL INPATIENT AND CURRENTLY DOES NOT HAVE ENTERAL FEEDING ACCESS. THE CLINICIAN WHO PLACED THE TUBE WAS NOT TRAINED DURING THIS PERIOD, BUT PER AVANOS CLINICAL EDUCATION SPECIALIST REPORT, WAS TRAINED DURING A PILOT INITIATIVE BETWEEN AUGUST AND (B)(6) 2023. TO MY KNOWLEDGE, THE HOSPITAL IS NOT REPORTING THIS AS AN EQUIPMENT OR TUBE MALFUNCTION.¿ PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, ¿LESS THAN 24 H FROM WHEN TUBE WAS PLACED TO FOLLOW UP CHEST CT IDENTIFYING NO FEEDING TUBE IN PLACE AND NO EVIDENCE OF PNEUMOTHORAX.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460819 ↗
• InjuryMay 20, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, A PNEUMOTHORAX OCCURRED WITH CORTRAK.

  Patient problems: Pneumothorax

  MAUDE report 19354432 ↗