CORLITE Enteral Feeding Tube 41-1368Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815149021284), received between Jul 28, 2017 and Jul 28, 2017 — classified as 2 deaths.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT FROM THE (B)(6), STATING A CORFLOW NASOGASTRIC TUBE WAS INSERTED INTO A PATIENT FOR FEEDING PURPOSES FOLLOWING A EPISODE OF ASPIRATION. ON POST INSERTION CHEST X-RAY A LARGE LEFT PNEUMOTHORAX WAS NOTED, WITH THE NASOGASTRIC TUBE FOLLOWING THE TRACHEA, DEVIATING INTO THE LEFT MAIN BRONCHUS AT THE CARINA. THE TIP OF THE TUBE WAS NOTED IN THE LEFT DIAPHRAGMATIC SULCUS, APPEARING TO LIE OUTSIDE OF THE BOUNDARIES OF THE LEFT LUNG. OUR IMPRESSION WAS THAT THE NASOGASTRIC TUBE (NG) TUBE HAD BEEN INSERTED ERRONEOUSLY INTO THE TRACHEA AND HAD TRACKED INTO THE LEFT LUNG VIA THE LEFT MAIN BRONCHUS. IT HAD THEN PERFORATED THROUGH THE LUNG PARENCHYMA AND CAUSED A LUNG INJURY RESULTING IN THE PNEUMOTHORAX. THE PATIENT SUSTAINED A PNEUMOTHORAX REQUIRING CHEST DRAIN INSERTION. THE PNEUMOTHORAX RESOLVED FOLLOWING DRAIN INSERTION BUT THE PATIENT DIED ON (B)(6) 2017. THE NG WAS TUBE REMOVED IMMEDIATELY ON DIAGNOSIS OF PNEUMOTHORAX AND PATIENT REFERRED TO RESPIRATORY TEAM WHO INSERTED A CHEST DRAIN TO GOOD EFFECT. ADDITIONAL INFORMATION RECEIVED 14-JUL-2017 STATED, THE PATIENT DIED (B)(6) 2017, CAUSE OF DEATH (AS PER THE CERTIFICATE) PNEUMONIA, CEREBRAL VASCULAR ACCIDE

  Patient problems: Death; Perforation; Pneumothorax

  MAUDE report 6750103 ↗
• DeathJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT FROM THE (B)(6), STATING "A CORFLOW NASOGASTRIC TUBE WAS SITED TOR FEEDING PURPOSES ON (B)(6) 2017. ON THE SUBSEQUENT CHECK CHEST X-RAY, IT WAS NOTED TO LIE IN THE RIGHT LUNG AND A RIGHT APICAL PNEUMOTHORAX WAS ALSO NOTED. THERE HAD BEEN NO PNEUMOTHORAX ON PREVIOUS CHEST X-RAYS AND THE PATIENT HAD NOT SHOWN CLINICAL SIGNS OF A PNEUMOTHORAX. OUR IMPRESSION WAS THAT THE NG TUBE HAD CAUSED A LUNG INJURY RESULTING IN THE DEVELOPMENT OF THE PNEUMOTHORAX. SMALL VOLUME RIGHT PNEUMOTHORAX, MANAGED CONSERVATIVELY TO GOOD EFFECT. AT TIME: NG TUBE REMOVED IMMEDIATELY UNFORTUNATELY DISPOSED OF BY WARD STAFF PRIOR TO ESCALATION OF INCIDENT), RESPIRATORY OPINION SOUGHT." ADDITIONAL INFORMATION RECEIVED 14-JUL-2017 STATED, " THE DEATH OF THE PATIENT WAS (B)(6) 2017, THE CAUSE OF DEATH WAS (AS PER DEATH CERTIFICATE) ASPIRATION PNEUMONIA, SEVERE VASCULAR DEMENTIA, HYPERTENSION, TYPE-2 DIABETES MELLITUS, CEREBRAL VASCULAR ACCIDENT AND PARKINSONISM.

  Patient problems: Death; Pneumothorax

  MAUDE report 6750102 ↗