CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9438TRAK2Recalls & reported problems
Corpak Medsystems, Inc. · Feeding tube non weighted with stylet for use with CORTRAK 2 Enteral Access System · Class 2
Data updated Oct 18, 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 10815149024018), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 18, 2026.
Most reported problems
Device problems
- Difficult or Delayed Positioning1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT A NURSE MADE A PLACEMENT ATTEMPT WITH THE CORTRAK UNIT BUT WAS EXPERIENCING DIFFICULTY. ANOTHER NURSE ATTEMPT TO PLACE THE TUBE BLINDLY WITHOUT THE USE OF THE CORTRAK UNIT. A X-RAY WAS TAKEN AND IT REVEALED THAT THE TUBE WAS IN THE RIGHT LUNG WITH A SMALL APICAL PNEUMOTHORAX. IT WAS NOTED THAT THE DIFFICULTY WITH PLACEMENT COULD BE BECAUSE OF POSSIBLE HETEROTAXY SYNDROME AS THE PATIENT'S STOMACH AND SPLEEN WERE BOTH ON THE RIGHT SIDE. THE PATIENT REMAINED INTUBATED WITH NO OTHER INTERVENTION REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 29-AUG-2018 STATED THAT THE TUBE INVOLVED IN THE INCIDENT WAS THE SAME TUBE THAT WAS INITIALLY ATTEMPTED WITH THE CORTRAK UNIT.
Patient problems: Pneumothorax
MAUDE report 7849972 ↗
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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