Cortrak 2 Enternal access deviceRecalls & reported problems across all models
Avanos Medical, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 164
- Deaths reported
- 7
- Injuries reported
- 28
- Recalls
- 0
We found 14 models of Cortrak 2 Enternal access device by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 164 adverse event reports in the FDA's MAUDE database, received between Jan 22, 2021 and Sep 29, 2026 — classified as 7 deaths, 28 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Break” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cortrak 2 Enternal access device problems
Device problems
- Break36
- Malposition of Device24
- Material Rupture22
- Material Puncture/Hole17
- Complete Blockage16
- Obstruction of Flow16
- Difficult to Remove9
- Fracture9
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- Foreign Body In Patient45
- Insufficient Information14
- Pneumothorax12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Discomfort4
- Perforation of Esophagus4
- Bowel Perforation3
Cortrak 2 Enternal access device models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cortrak 2 Enternal access device 46053Tubes, gastrointestinal (and accessories)3 deaths69 reports
- Cortrak 2 Enternal access device 46047Tubes, gastrointestinal (and accessories)2 deaths53 reports
- Cortrak 2 Enternal access device 45818Tubes, gastrointestinal (and accessories)9 reports
- Cortrak 2 Enternal access device 46098Tubes, gastrointestinal (and accessories)1 death8 reports
- Cortrak 2 Enternal access device 20-0950Tubes, Gastrointestinal (And Accessories)5 reports
- Cortrak 2 Enternal access device 46044Tubes, gastrointestinal (and accessories)5 reports
- Cortrak 2 Enternal access device 45797Tubes, gastrointestinal (and accessories)4 reports
- Cortrak 2 Enternal access device 46100Tubes, gastrointestinal (and accessories)3 reports
- Cortrak 2 Enternal access device 20-0950Tubes, Gastrointestinal (And Accessories)1 death2 reports
- Cortrak 2 Enternal access device 46093Tubes, gastrointestinal (and accessories)2 reports
- Cortrak 2 Enternal access device 45802Tubes, gastrointestinal (and accessories)1 report
- Cortrak 2 Enternal access device 46049Tubes, gastrointestinal (and accessories)1 report
- Cortrak 2 Enternal access device 46051Tubes, gastrointestinal (and accessories)1 report
- Cortrak 2 Enternal access device 46055Tubes, gastrointestinal (and accessories)1 report
Recent Cortrak 2 Enternal access device adverse event reports
The 15 most recent reports across all models, 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 10, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50192241 ↗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 29, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072897 ↗MalfunctionJul 29, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072891 ↗MalfunctionJul 29, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072890 ↗MalfunctionJul 8, 2026Obstruction of Flow; Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 25749199 ↗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 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 recalls
- Ballard* Closed Suction System for Adults17 models · 121 reports · 3 recalls
- CORTRAK* 2 Enteral Access System2 models · 134 reports · 1 recall
- NEOMED*24 models · 0 reports · 3 recalls
- Microcuff* Endotracheal Tube for Adults8 models · 102 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW*2 models · 94 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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