CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 40-9368TRAK2Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815149020874), received between Aug 27, 2019 and Sep 26, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2019Break; Break
AN FDA USER FACILITY REPORT NUMBER (B)(4) WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: A NASOGASTRIC TUBE WAS INSERTED UNDER DIRECT FLUOROSCOPY. THE NASOGASTRIC TUBE REMAINED INTACT UNTIL APPROXIMATELY FIVE DAYS LATER WHEN X-RAYS SHOWED THAT THE TIP HAD BROKEN OFF AND WAS NOTED TO BE IN THE COLON. ORIGINAL INTENDED PROCEDURE: ENTERAL FEEDING. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 9126471 ↗MalfunctionAug 27, 2019Break
A NASOGASTRIC TUBE WAS INSERTED UNDER DIRECT FLUOROSCOPY. THE NASOGASTRIC TUBE REMAINED INTACT UNTIL APPROXIMATELY FIVE DAYS LATER WHEN X-RAYS SHOWED THAT THE TIP HAD BROKEN OFF AND WAS NOTED TO BE IN THE COLON.
Patient problems: Foreign Body In Patient
MAUDE report 8935408 ↗
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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