Cortrak 2 Enternal access device 46044Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770460444), received between May 27, 2022 and Jun 9, 2026 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  THE CUSTOMER REPORTED THAT A FEEDING TUBE BROKE WHILE IN USE AND THAT A PORTION OF THE DEVICE BROKE INSIDE THE PATIENT. THE CUSTOMER SUBSEQUENTLY REQUESTED MANUFACTURER FLUSHING GUIDELINES FOR THE FEEDING TUBE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25448977 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT A CORTRAK FEEDING TUBE WAS FOUND TO BE FRAYED AND PARTIALLY BROKEN IN THE MID-SECTION AFTER REMOVAL FROM THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443423 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED VIA FDA USER FACILITY REPORT MW REPORT MW5146866 THE FOLLOWING INFORMATION: ON (B)(6) 2023, THE PATIENT'S NASAL DUODENAL (ND) TUBE CLOGGED AND DESPITE MULTIPLE ATTEMPTS TO FLUSH AND USE CLOT-BUSTER MEDICATIONS, OBSTRUCTION WAS NOT CLEARED. WHEN ND WAS PULLED, THE DISTAL PORTION BROKE OFF AND REMAINS IN PATIENT'S ESOPHAGUS. GI WAS CONSULTED AND PATIENT WAS TAKEN TO OPERATING ROOM ON (B)(6) 2023 TO HAVE SURGICALLY REMOVED. PORTION OF THE PRODUCT WAS SAVED. ADDITIONAL INFORMATION RECEIVED 01-NOV-2023 STATING THE PATIENT RETURNED TO (OPERATING ROOM) OR FOR REMOVAL OF THE DEVICE. THE DEVICE WAS INITIALLY INSERTED ON (B)(6) 2023. THE PATIENT IS CURRENTLY DECEASED, NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18133936 ↗
• InjuryAug 4, 2022Material Fragmentation; Material Fragmentation

  FDA MEDWATCH / FDA USER FACILITY REPORT # MW 0504540000-2022-8016, REPORTED, THE 8FR CORTRAK 2 NASOJEJUNAL (NJ) TUBE WAS PLACED TO ADMINISTER NJ GASTRIC FEEDINGS AND ORAL MEDICATIONS. 10 DAYS LATER THE TUBE WAS CLAMPED, CLOG ZAPPER USED, MEDICATIONS AND FLUSH. AN X-RAY WAS PERFORMED APPROXIMATELY 2 WEEKS LATER AND THE ENTERIC TUBE APPEARED FRACTURED WITH THE TIP REMAINING AT THE FOURTH PORTION OF THE DUODENUM. THE TUBE WAS REMOVED WITH 3CM OF THE TUBE MISSING. THE FRACTURED ENTERIC TUBE WAS SEEN ON IMAGING AND THE DISTAL PORTION HAD MIGRATED BEYOND POINT OF ENDOSCOPIC RETRIEVAL; NO ENTERAL TUBE WAS PLACED. THE PATIENT REPORTEDLY RECEIVED PACKET RED BLOOD CELL (PRBC) X 1, PLATELET COUNT (PLT) X 2 AND 2 PLATELET TRANSFUSIONS DUE TO GASTROINTESTINAL (GI) BLEEDING. IT IS UNKNOWN IF THE DISTAL PORTION WAS REMOVED VIA MEDICAL INTERVENTION.

  Patient problems: Foreign Body In Patient; Unspecified Gastrointestinal Problem

  MAUDE report 15166834 ↗
• MalfunctionMay 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CORTRAK TUBE WAS PLACED ON (B)(6) 2022 AND WAS REMOVED, BY ESOPHAGOGASTRODUODENOSCOPY (EGD) DUE TO IT BEING DAMAGED, (IT WAS BROKEN IN HALF). THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14529558 ↗