Cortrak 2 Enternal access device 20-0950 (UDI 00350770005843)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770005843), received between Oct 31, 2024 and Feb 7, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED "A CVICU [CARDIOVASCULAR INTENSIVE CARE UNIT] PATIENT HAD MULTIPLE NG [NASOGASTRIC] SALEM SUMP TUBE ATTEMPTS BY NURSING AND TEE [TRANSESOPHAGEAL ECHOCARDIOGRAM] PERFORMED. AFTER UNSUCCESSFUL NG TUBE ATTEMPTS, RD'S [REGISTERED DIETICIAN'S] NOTIFIED TO PLACE CORTRAK TUBE. RD REPORTED CORTRAK TUBE SMOOTHLY PLACED AND KUB [KIDNEY, URETER, AND BLADDER] STATED CORTRAK WAS PLACED IN STOMACH. PATIENT WAS FED THROUGH CORTRAK TUBE. IT WAS LATER DISCOVERED THAT THE CORTRAK TUBE HAD BEEN PLACED THROUGH AN ESOPHAGEAL PERFORATION; CLINICIANS UNSURE WHETHER CORTRAK TUBE OR NGT [NASOGASTRIC TUBE] CAUSED PERFORATION."

  Patient problems: Perforation of Esophagus

  MAUDE report 21334316 ↗
• InjuryDec 27, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED "A PATIENT HAD A LUNG INCIDENT AND SUBSEQUENTLY HAD A CHEST TUBE PLACED. PATIENT IS NOW IN RECOVERY."

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21029052 ↗
• InjuryDec 12, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THE CORTRAK DEVICE WAS USED ON A GASTRIC BYPASS. THE USER REPORTS. "UNFORTUNATELY HAD A BAD COMPLICATION AFTER A PLACEMENT RECENTLY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20921439 ↗
• InjuryDec 12, 2024Malposition of Device; Physical Resistance/Sticking; Malposition of Device; Physical Resistance/Sticking

  IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2024. INITIALLY INTUBATED (B)(6) 2024 WITH OGT (ORAL GASTRIC TUBE) IN PLACE, EXTUBATED. ON "(B)(6) 2024 AND OGT WAS PULLED UPON EXTUBATION (B)(6) 2024 ATTEMPTED CORTRAK PLACEMENT...AT TIME OF PLACEMENT PATIENT (PT) WAS ON 50L HEATED HIGH FLOW O2 (OXYGEN) PLUS 15L O2 VIA MASK. PER CLINICIAN PLACING TUBE, [PATIENT] WAS COUGHING/MOVING DURING PLACEMENT. ON LAST PLACEMENT ATTEMPT, [PATIENT] [COMPLAINED OF] PAIN ON [RIGHT] SIDE, CLINICIAN STATES THEY FELT RESISTANCE, FINAL TRACING APPEARS TO SHOW FEEDING TUBE TIP ENTER THE [RIGHT] LUNG THEN ENTIRE FEEDING TUBE WAS IMMEDIATELY REMOVED, [PATIENT'S] O2 STATS DROPPED TO HIGH 70S - LOW 80S, TACHYPNEIC (30-40 BPM [BEATS PER MINUTE]), [PATIENT] WAS INTUBATED AT 1407 ON (B)(6) 2024, CHEST [X-RAY] OBTAINED, RADIOLOGIST INTERPRETATION: INTERVAL DEVELOPMENT OF A SMALL THE MODERATE RIGHT-SIDED PNEUMOTHORAX WITH THE PLEURAL SURFACE APPROXIMATELY 3 CM FROM THE APEX. CHEST TUBE PLACED (B)(6) 2024, THEN REPLACED [DUE TO] MALPOSITION AND REPLACED A SECOND TIME ON (B)(6) 2024 (THREE CHEST TUBES TOTAL). AS OF (B)(6) 2024 [PATIENT] REMAINS INTUBATED WITH OGT AND CHEST TUBE IN PLACE. HOSPITAL P

  Patient problems: Chest Pain; Cough; Low Oxygen Saturation; Pneumothorax

  MAUDE report 20915475 ↗
• InjuryOct 31, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED DURING USE OF A CORTRAK DEVICE FEEDING TUBE WENT INTO THE PATIENT'S LUNGS OF A PATIENT IN THE INTENSIVE CARE UNIT (ICU) AND FEEDING SOLUTION WAS INFUSED INTO THE LUNGS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20580122 ↗