CORTRAK 2EAS P20-0950Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10815149024698), received between Dec 20, 2016 and Jun 20, 2018 — classified as 3 deaths, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathJun 20, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS INITIALLY REPORTED THAT THE SRU PORTS DID NOT WORK ON A CORTRAK UNIT. THE USER WAS UNABLE TO PRINT OR DOWNLOAD PLACEMENT FILES. THE PRINTER FROM THE PROBLEM UNIT WAS SWAPPED TO ANOTHER UNIT AND IT WORKED WITHOUT ISSUE. THE ISSUE SURROUNDED THE USB PORTS. FURTHER INFORMATION RECEIVED ON 21-MAY-2018 STATED THAT A PATIENT EXPERIENCED PNEUMOTHORAX AFTER PLACEMENT. HOWEVER, THE CORTRAK TRACING AND X-RAY VERIFIED THAT THE TUBE WAS PLACED CORRECTLY. THE FACILITY DID NOT FEEL THAT THE PNEUMOTHORAX WAS A RESULT OF THE NASOGASTRIC (NG) TUBE PLACEMENT. ADDITIONAL INFORMATION RECEIVED ON 30-MAY-2018 STATED THAT THE NG TUBE WAS FOUND IN THE PLUERAL SPACE ON (B)(6) 2018. THE TUBE WAS PLACED ON (B)(6) 2018 AND THE FACILITY STATED THAT THE EVENT OCCURRED DUE TO USER ERROR. THE ONLY ISSUE WAS THAT THE UNIT WAS NOT PRINTING THE TRACING. THE PATIENT LATER EXPIRED ON (B)(6) 2018, BUT IT WAS NOTED AS UNRELATED TO THIS EVENT.

  Patient problems: Death; Pneumothorax

  MAUDE report 7620901 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PNEUMOTHORAX WAS DISCOVERED AFTER THE NASOGASTRIC TUBE (NGT) PLACEMENT. THE X-RAY REVEALED A LUNG PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND A PIGTAIL CATHETER WAS INSERTED TO AID IN RESOLVING THE PNEUMOTHORAX. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 7477846 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PNEUMOTHORAX WAS DISCOVERED AFTER THE NASOGASTRIC TUBE (NGT) PLACEMENT. THE TRACING ON THE CORTRAK DEVICE SHOWED SOME DEVIATION TO THE RIGHT OF THE DISPLAY. THE PATIENT EXPERIENCED SHORTNESS OF BREATH WITH COUGHING SO AN X-RAY WAS PERFORMED. THE X-RAY REVEALED A RIGHT LUNG PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND A PIGTAIL CATHETER WAS INSERTED TO AID IN RESOLVING THE PNEUMOTHORAX. THE PATIENT WAS TRANSITIONED TO COMFORT ONLY MEASURES, HOWEVER THIS WAS NOT RELATED TO THE PNEUMOTHORAX. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 7477837 ↗
• DeathApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A MEDWATCH REPORT NUMBER 5075441 WAS RECEIVED ON 21-MAR-2018 "THE PATIENT WAS ORDERED BY THE PROVIDER TO HAVE A POST PYLORIC FEEDING TUBE INSERTED. THE NURSE USED THIS PIECE OF EQUIPMENT WHILE INSERTING THE TUBE. AN X-RAY CONFIRMED THAT THE TUBE WAS PLACED IN THE PATIENT¿S LUNG CAUSING A PNEUMOTHORAX. THE PATIENT HAD AN ARREST LEADING TO A CODE BLUE." ADDITIONAL INFORMATION WAS RECEIVED ON 30-MAR-2018 FROM THE RISK MANAGER WHO STATED THE PATIENT HAD A CARDIAC RESPIRATORY ARREST THAT LEAD TO AN PEA PULSELESS ELECTRICAL ACTIVITY. THE PATIENT RECEIVED MEDICAL INTERVENTION IN THE FORM OF A CHEST TUBE, INTUBATION, NEEDLE DECOMPRESSION, CHEST TUBE AND A RIGHT FEMORAL ART LINE INSERTED. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 7433797 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA USER FACILITY REPORT NUMBER ¿ (B)(4). THAT A MALE PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH SYMPTOMS SIGNIFYING ACUTE APPENDICITIS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY, APPENDECTOMY, AND A SMALL BOWEL RESECTION WITH A REQUIRED PRIMARY ANASTOMOSIS. IT WAS DISCOVERED THAT THE PATIENT HAD EXTENSIVE ADHESIONS AND INFLAMMATORY CHANGES IN THE APPENDIX WITH A GROSS PERFORATION AND FECAL PERITONITIS. THE PATIENT WAS CONSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU). NEPHROLOGY WAS CONSULTED THE FOLLOWING DAY AND CONCLUDED AN ACUTE KIDNEY INJURY AS A RESULT OF HYPOTENSION AND SEPSIS IN ADDITION TO STAGE IV CHRONIC KIDNEY DISEASE. PALLIATIVE CARE WAS ALSO CONSULTED. THE PATIENT WAS DELIRIOUS ON A PRECEDEX DRIP, HAD FLUID OVERLOAD, ATRIAL FIBRILLATION, AND WAS AT RISK FOR ASPIRATION. THE PATIENT AND HIS WIFE DID NOT WANT TO RESULT TO AGGRESSIVE MEASURES OR DIALYSIS. HIS CODE STATUS WAS CHANGED TO DO NOT RESUSCITATE OR DO NOT INTUBATE. A FEW DAYS LATER THE PATIENT WAS TRANSFERRED TO A P6 CARDIAC TELEMETRY WHERE HE WAS NOT ABLE TO TOLERATE TUBE FEEDINGS WITH A NASOGASTRIC TUBE, BUT WAS ABLE TO GO OUT INTO THE HALLWAY IN

  Patient problems: Confusion/ Disorientation; Hemothorax; Low Oxygen Saturation; Pneumothorax

  MAUDE report 7177843 ↗
• InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED STATING THE STAFF STATES THE CORTRAK IS NOT PLACING PROPERLY. BIOMED IS AWARE OF 1 LUNG PLACEMENT AND POSSIBLY 2 MORE OCCURRENCES OF MISPLACEMENT THAT WERE NOT IN THE LUNG. BIOMED DOES NOT HAVE ANY FURTHER DETAILS. ADDITIONAL INFORMATION RECEIVED (B)(6) 2017 STATED THE STAT REGISTERED NURSE (RN) PLACED THE TUBE AND THE PATIENT HAD A SUBSEQUENT PNEUMOTHORAX. PRIOR TO THE INCIDENT THE CORTRAK UNIT DISPLAY TRACINGS HAD BEEN GOING ON AND OFF. THE PATIENT DEVELOPED A PNEUMOTHORAX AND REQUIRED A PIGTAIL COMPUTED TOMOGRAPHY (CT) CATHETER TO BE PLACED. ANOTHER FEEDING TUBE WAS PLACED USING THE "BLIND" TECHNIQUE. ON THE PREVIOUS DAY THE CORTRAK UNIT HAD BEEN DISPLAYING THE TRACINGS "ON AND OFF." THE PATIENT WAS REPORTED TO BE STABLE FROM THIS INJURY. ADDITIONAL INFORMATION RECEIVED 26-JUN-2017 STATED IT IS UNKNOWN HOW MANY MISPLACEMENTS OCCURRED AND THE LOCATION OF THE MISPLACEMENT. THE CUSTOMER STATED "I AM SORRY BUT I DO NOT. IT WAS AWHILE BACK AND I AM NOT SURE IF IT WAS THIS MACHINE OR NOT." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 6702582 ↗
• InjuryJul 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN NASOGASTRIC (NG) TUBE WAS PLACED INTO THE RIGHT LUNG OF THE PATIENT BY THE END-USER IN THE INTENSIVE CARE UNIT (ICU). IT WAS NOTED THAT THERE WAS NO FAULT WITH THE PLACEMENT SYSTEM, BUT IT WAS CONCLUDED THAT THE END-USER OF THE SYSTEM PLACED THE TUBE INTO THE LUNG ERRONEOUSLY. THE TRACING ON THE PRINTOUT AND ON THE MONITOR SHOWED THAT THE TUBE WAS FEEDING INTO THE LUNG, BUT THE END-USER DID NOT STOP. THE PATIENT EXPERIENCED SHORTNESS OF BREATH, AND WAS GIVEN AN X-RAY, WHICH SHOWED THE TUBE IN THE LUNG. THE PATIENT WAS NOTED TO HAVE PLEURAL EFFUSION, AND CONSEQUENTLY HAD A CHEST TUBE PLACED. CURRENTLY, THE PATIENT IS STABLE IN THE ICU WITH NO ADDITIONAL NG TUBE PLACED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Dyspnea; Pleural Effusion

  MAUDE report 6684112 ↗
• MalfunctionJun 15, 2017Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PLACEMENT OF A FEEDING TUBE WAS PERFORMED UTILIZING THE SYSTEM, WITH THE SMART RECEIVER UNIT POSITIONED ON THE CHEST AND SECURED WITH TAPE. THE INITIAL INSERTION WAS UNEVENTFUL. HOWEVER, POST PROCEDURE, AND X-RAY DISCOVERED THE FEEDING TUBE TO BE LOCATED IN THE LEFT LUNG. THE TUBE WAS IMMEDIATELY REMOVED AND REPLACED PER ORDERS. THE PATIENT DID NOT EXPERIENCE ANY PNEUMOTHORAX UPON REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 6644321 ↗
• DeathJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A PNEUMOTHORAX FOLLOWING A DIFFICULT NASOGASTRIC TUBE (NGT) PLACEMENT. WITHIN 10 MINUTES OF THE PLACEMENT, AN X-RAY CONFIRMED THAT THE NGT WAS NOT IN THE GASTRIC REGION. THE NGT WAS IMMEDIATELY WITHDRAWN AND A CHEST TUBE WAS INSERTED. IT WAS NOTED THAT THE PATIENT WAS ADMITTED WITH A BRAIN STEM INJURY AND EXPIRED EIGHT DAYS LATER. ADDITIONAL INFORMATION RECEIVED ON 19-MAY-2017 STATED THAT A CLINICIAN PLACED THE TUBE WITH THE ASSISTANCE OF THE COTRAK ENTERAL ACCESS SYSTEM. AN X-RAY CONFIRMATION WAS TAKEN TO VERIFY THE LOCATION OF THE PLACEMENT. THE X-RAY REVEALED THAT THE TUBE EXTENDED INTO THE LEFT MAINSTEM WITH NO OBVIOUS PNEUMOTHORAX AT THE TIME. THE PNEUMOTHORAX DEVELOPED AFTER REMOVAL WHEN THE CHEST TUBE WAS PLACED.

  Patient problems: Death; Pneumothorax

  MAUDE report 6630138 ↗
• InjuryDec 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE WAS PLACING A FEEDING TUBE ON (B)(6) 2016 USING CORTRAK, THE PATIENT BEGAN TO SHOW SYMPTOMS OF RESPIRATORY DISTRESS, X-RAY INDICATED THE FEEDING TUBE WAS IN THE RIGHT LUNG INDICATIVE OF A RIGHT LUNG PNEUMOTHORAX. CORTRAK TUBE WAS WITHDRAWN AND PATIENT WAS TREATED FOR RIGHT LUNG PNEUMOTHORAX. PATIENT STABLE AND EXPECTED TO RECOVER WITHOUT FURTHER INCIDENT.

  Patient problems: Pneumothorax

  MAUDE report 6189163 ↗