Cortrak 2 Enternal access device 45797Recalls & reported problems

Avanos Medical, Inc. · CORTRAK* 2 Nasogastric/Nasointestinal Feeding Tube with Electromagnetic Transmitting Stylet · Class 2

All models of Cortrak 2 Enternal access device (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770457970), received between Dec 1, 2023 and Feb 28, 2024 — classified as 3 injuries, 1 malfunction.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Malposition of Device3
Material Puncture/Hole1

Patient problems

Pneumothorax3
Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryFeb 28, 2024Malposition of Device; Malposition of Device
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2024-00031 FOR THE FIRST REPORT. REFER TO 9611594-2024-00032 FOR THE SECOND REPORT. IT WAS REPORTED, ¿THEY HAVE SEEN AN INCREASE IN PNEUMOTHORAX OCCURRENCES RELATING TO DOBHOFF TUBE (DHT) INSERTION.¿
Patient problems: Pneumothorax
MAUDE report 18798045 ↗
InjuryFeb 28, 2024Malposition of Device; Malposition of Device
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2024-00031 FOR THE FIRST REPORT REFER TO 9611594-2024-00033 FOR THE THIRD REPORT IT WAS REPORTED, ¿THEY HAVE SEEN AN INCREASE IN PNEUMOTHORAX OCCURRENCES RELATING TO DOBHOFF TUBE (DHT) INSERTION.¿
Patient problems: Pneumothorax
MAUDE report 18798031 ↗
InjuryFeb 28, 2024Malposition of Device; Malposition of Device
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2024-00032 FOR THE SECOND REPORT. REFER TO 9611594-2024-00033 FOR THE THIRD REPORT. IT WAS REPORTED, ¿THEY HAVE SEEN AN INCREASE IN PNEUMOTHORAX OCCURRENCES RELATING TO DOBHOFF TUBE (DHT) INSERTION.¿
Patient problems: Pneumothorax
MAUDE report 18798028 ↗
MalfunctionDec 1, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED, THE ELECTROMAGNETIC WIRE WENT THROUGH THE TUBE TIP. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18244237 ↗

Device details

UDI-DI	`00350770457970`
Brand	Cortrak 2 Enternal access device
Model	45797
Catalog no.	20-9431TRAK2
Company	Avanos Medical, Inc.
Product code	KNT · Tubes, gastrointestinal (and accessories)
Class	Class 2
FDA submission	K220588
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 8, 2023

Device type (GMDN): Nasogastric feeding tube

A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.

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All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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