Cortrak 2 Enternal access device 45802Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770458021), received between Mar 16, 2021 and Mar 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2021Break; Break
AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00043 FOR THE SECOND EVENT. IT WAS REPORTED ON (B)(6) 2021 AT 1900, THE PATIENT WAS ADMITTED WITH DYSPNEA ON EXERTION AND LEG SWELLING. THE 'DOBHOFF' WAS PLACED FOR TUBE FEEDING (TF) ON (B)(6) 2021 AT 2000. THE PATIENT WAS NOTED TO HAVE SIGNIFICANT TF RESIDUALS. THE TF WAS HELD FOR 2 HOURS ON (B)(6) 2021 AT 2300. THE TF WAS RESTARTED ON (B)(6) 2021 AT 0115. CLOG ZAPPER WAS INFUSED INTO THE DIGESTIVE HEALTH TUBE (DHT). A WIRE WAS INSERTED DUE TO BLOCKAGE ON (B)(6) 2021. IN THE MORNING AN X-RAY WAS REVIEWED AND NOTED THAT THE TUBE MAY HAVE BEEN TRANSECTED ON (B)(6) 2021 IN THE AFTERNOON. THE X-RAY SHOWED THE RESECTED DHT IN THE PATIENT'S STOMACH ON (B)(6) 2021 AT 1700. AN EGD WAS PERFORMED AT THE PATIENT'S BEDSIDE AND THE 'DOBHOFF' FRAGMENTS WERE NOTED IN THE PATIENT'S STOMACH. THE CLINICIAN SUCCESSFULLY REMOVED THE BROKEN DEVICE FRAGMENTS. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021 STATED IT WAS NOT CONFIRMED IF THE CLINICIANS WAITED THE RECOMMENDED 30-60 MINUTES ONC
Patient problems: Foreign Body In Patient
MAUDE report 11499904 ↗
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-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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