CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9432TRAK2Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815149023974), received between Aug 20, 2018 and Aug 20, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
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.
InjuryAug 20, 2018Malposition of Device; Malposition of Device
AN FDA MEDWATCH REPORT, MW5078400, WAS RECEIVED STATING: ON (B)(6) 2018. IT WAS NOTED THAT THE PT HAD A POSSIBLE CUFF LEAK WITH NOTED AIR REPLACED INTO THE BALLOON. ATTEMPTS WERE MADE TO TRANSITION PT TO TRACH COLLAR AND SHE BEGAN TO TRANSITION TO A DYSPHAGIA II DIET. ON (B) (6) 2018 AS SHE PROGRESSED THERE WAS A STRONG PUSH FROM BOTH NUTRITION AND CASE MANAGEMENT TO GET THE TUBE CHANGED OVER TO A CORTRACK (SMALL BORE) FEEDING TUBE. THE NURSE WHOM HAD THE PT HAD BEEN TRAINED IN CORTRAK DEVICES. BUT HAD NOT YET BEEN GIVEN AN ACCESS ID TO WORK INDEPENDENTLY IN THE CORTRAK MACHINE WITH THE TRACER DEVICE. THE NURSE NOTED THAT IT WAS A MODERATELY BUSY DAY AND REMEMBERED THAT THE PHYSICIAN WANTED THE TUBE PLACED POST PYLORIC. THE SUPER-USER RESOURCE NURSE NOTED THAT IT WAS AVAILABLE TO THE NURSE WHO HAD THE PT WAS BUSY IN A ROOM CLOSE BY WITH ANOTHER PT WHOM WAS ACTIVELY WITHDRAWING FROM ALCOHOL AND REQUIRING A GREAT DEAL OF THE RESOURCES TIME TO MAINTAIN SAFETY FOR. THE NURSE PLACING THE TUBE IS A NEWER NURSE LESS THAN 1 YEAR EXPERIENCE AND JUST OFF ORIENTATION. THERE WAS A FAMILY MEETING LATER IN THE DAY, FOR WHICH THE REQUEST WAS MADE THAT THE CORTRAK TUBE BE PLACED PRIOR TO THIS. CON
Patient problems: Pneumothorax
MAUDE report 7797929 ↗
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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