Cortrak 2 Enternal access device 46053Recalls & reported problems
Avanos Medical, Inc. · CORTRAK* 2 Nasogastric/Nasointestinal Feeding Tube with Electromagnetic Transmitting Stylet with ENFit® Connector · Class 2
All models of Cortrak 2 Enternal access device (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Avanos Cortrak 2 feeding tube is a nasogastric/nasointestinal tube with a metal stylet used to guide placement. Most of the 69 reports describe the tube splitting, cracking or snapping, or blocking up so it stops flowing and has to be unclogged, sometimes leaving pieces that need to be retrieved. Three deaths and one injury are mentioned, along with 65 malfunctions. No recalls name this device. Reports have risen sharply, from 7 in the prior 12 months to 39 in the most recent 12.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 69
- Deaths reported
- 3
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00350770460536), received between Mar 16, 2021 and Sep 29, 2026 — classified as 3 deaths, 1 injury, 65 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (15 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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage15
- Break13
- Material Rupture13
- Material Puncture/Hole8
- Difficult to Remove7
- Obstruction of Flow6
- Fracture5
- Leak/Splash5
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Foreign Body In Patient15
- Insufficient Information7
- Discomfort3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Cough1
- Dyspnea1
- Irritability1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Remove
Patient problems: Discomfort
MAUDE report 50937899 ↗MalfunctionSep 29, 2026Difficult to Remove
Patient problems: Discomfort
MAUDE report 50937888 ↗MalfunctionSep 29, 2026Difficult to Remove
Patient problems: Discomfort
MAUDE report 50937885 ↗MalfunctionAug 18, 2026Difficult to Insert; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307583 ↗MalfunctionAug 18, 2026Difficult to Insert; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307534 ↗MalfunctionAug 18, 2026Difficult to Insert; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307516 ↗MalfunctionAug 18, 2026Difficult to Insert; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307511 ↗MalfunctionAug 7, 2026Break
It was Enfit digestive health tube ruptured with an attempt to unclog after medications were given. The rupture was proximal, just below the port. The tube was removed intact, no harm to patient, and replaced. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50180747 ↗MalfunctionJul 2, 2026Complete Blockage; Fracture
IT WAS REPORTED THAT A CORTRAK FEEDING TUBE RUPTURED PROXIMALLY DURING ATTEMPTS BY THE PATIENT TO UNCLOG THE TUBE AT HOME. THE TUBE WAS REMOVED INTACT AND NO HARM WAS REPORTED. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR TUBE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690514 ↗MalfunctionJul 2, 2026Complete Blockage; Material Rupture
IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE RUPTURED WHEN ATTEMPTING TO UNCLOG. PROXIMAL RUPTURE (BETWEEN PORT AND BRIDLE CLIP). TUBE REMOVED INTACT, AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690294 ↗MalfunctionJul 2, 2026Break; Complete Blockage
IT WAS REPORTED THAT A NASOGASTRIC TUBE BROKE DURING AN ATTEMPT TO UNCLOG. IT WAS REMOVED INTACT. NO HARM TO THE PATIENT, AND A REPLACEMENT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690286 ↗MalfunctionJul 2, 2026Material Perforation
IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS PERFORATED. IT WAS REMOVED INTACT. NO HARM TO THE PATIENT. THE TUBE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690283 ↗MalfunctionJun 18, 2026Complete Blockage; Material Rupture
IT WAS REPORTED THERE WAS A PROXIMAL RUPTURE AFTER ATTEMPTING TO UNCLOG THE TUBE. THE TUBE WAS REMOVED INTACT, NO HARM TO PATIENT. THE DEVICE WAS PLACED (B)(6) 2025 AND REMOVED (B)(6) 2025. THE TUBE BURST WAS OUTSIDE OF THE PATIENT. HAS BEEN SUBMITTED TO FDA, BUT UNKNOWN REFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552633 ↗MalfunctionJun 18, 2026Break; Complete Blockage
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00474 FOR THE FIRST REPORT REFER TO . IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE CLOGGED, AND IT BROKE IN TWO WHEN TRYING TO UNCLOG. THE BROKEN PART WAS RETRIEVED AT THE BACK OF THE THROAT. THE PATIENT HAD ALREADY BEEN SEDATED AND INTUBATED AT THE TIME OF OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552629 ↗MalfunctionJun 18, 2026Complete Blockage; Material Rupture
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00475 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE CLOGGED, AND IN TURN BURST WHEN THEY TRIED TO UNCLOG IT. IT WAS REMOVED INTACT. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552592 ↗MalfunctionJun 18, 2026Fracture
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00472 FOR THE FIRST REPORT. REFER TO 9611594-2026-00473 FOR THE SECOND REPORT. IT WAS REPORTED THAT A CORTRAK NASOGATRIC TUBE FRACTURED WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551574 ↗MalfunctionJun 18, 2026Deformation Due to Compressive Stress
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO FOR THE FIRST REPORT REFER TO 9611594-2026-00473 FOR THE SECOND REPORT. IT WAS REPORTED THAT A CORTRAK NASOGASTRIC (NG) TUBE BALLOONED OUT ON SATURDAY MORNING, WITNESSED BY NURSING, RENDERING THE TUBE UNSAFE FOR MEDICATION AND TUBE FEED ADMINISTRATION. NG TUBE HAD TO BE REPLACED, BUT TEAM COULD NOT ADVANCE THE TUBE POST-PYLORIC AT BEDSIDE. PATIENT HAD TO GO TO FLUOROSCOPY FOR TUBE ADVANCEMENT. IN FLUOROSCOPY, PATIENT HAD AN ACUTE DESATURATION AND WAS INTUBATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551573 ↗MalfunctionJun 16, 2026Complete Blockage
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00449 FOR THE FIRST REPORT. REFER TO 9611594-2026-00451 FOR THE THIRD REPORT. IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE WAS PLACED. IT CLOGGED AND WAS REMOVED ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25519013 ↗MalfunctionJun 16, 2026Complete Blockage
IT WAS REPORTED THAT A CORTRAK FEEDING TUBE BECAME CLOGGED DURING USE AND REQUIRED FORCEFUL FLUSHING ATTEMPTS TO CLEAR THE OBSTRUCTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. EVENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25518994 ↗MalfunctionJun 16, 2026Complete Blockage
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO FOR THE FIRST REPORT, REFER TO 9611594-2026-00450 FOR THE SECOND REPORT , REFER TO 9611594-2026-00451 FOR THE THIRD REPORT . IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE WAS PLACED. IT CLOGGED AND WAS REMOVED ON (B)(6) 2024. KCLOR CR GIVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25518988 ↗MalfunctionJun 9, 2026Leak/Splash
IT WAS REPORTED THAT A NASOGASTRIC TUBE DEVELOPED A LEAK AT THE CONNECTION BETWEEN THE TUBE AND PORT AFTER STYLET REMOVAL WHILE IN THE PATIENT, REQUIRING PLACEMENT OF A SECOND TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443454 ↗MalfunctionJun 9, 2026Fracture
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00222 FOR THE FIRST REPORT. IT WAS REPORTED THAT THERE WAS A PROXIMAL TEAR OUTSIDE OF THE PATIENT. NOTIFIED OF THIS INCIDENT DURING FOLLOW-UP FOR THE FIRST INCIDENT. EVENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443437 ↗MalfunctionJun 9, 2026Fracture; Material Puncture/Hole
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00223 FOR THE SECOND REPORT. IT WAS REPORTED THE USER REPLACED ANOTHER TUBE WITH A PROXIMAL TEAR IN TUBE. NO HARM TO PATIENT. TEAR MUST HAVE HAPPENED ON NIGHTS. THE DAY SHIFT NURSE SAID HE FOUND IT WITH HOLE AND HAS NO IDEA IF THERE WAS A CLOG. THE TUBE INDWELLING TIME IS UNKNOWN. THE PROXIMAL TEAR OCCURRED OUTSIDE OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443432 ↗MalfunctionMay 29, 2026Complete Blockage; Deformation Due to Compressive Stress
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING XX DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00378 FOR THE SECOND REPORT. IT WAS REPORTED THAT A BUBBLE FORMED IN THE NASOGASTRIC TUBE. IT WAS NOTED WHEN ATTEMPTING TO UNCLOG/FLUSH THE TUBE. IT WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332510 ↗MalfunctionMay 29, 2026Complete Blockage; Material Rupture
IT WAS REPORTED THAT A NG TUBE RUPTURED. MEDICATION HAD BEEN ADMINISTERED, AND THEN THERE WAS AN ATTEMPT TO UNCLOG. IT BURST OUTSIDE OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332485 ↗
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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