Devices › Tubes, gastrointestinal (and accessories)
Device brand name · Dh cortrak eas
CORTRAK 2 Enteral Access System: medical device reports filed with FDA
190 reports name it, 2014–2026. Manufacturer given most often on reports: Avanos Medical. Product code KNT.
- 190
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 37
- reports, 12 months to August 2026
- 19 in the 12 months before
- 8.4%
- classified as malfunction
- 47% across the product code
- 14.7%
- classified as death, as reported
- 28 reports · not verified by FDA
FDA's MAUDE database holds 190 reports that name the brand "CORTRAK 2 Enteral Access System" (dh cortrak eas), received between January 2014 and August 2026; the manufacturer given most often on reports is Avanos Medical. Spellings of one product vary from report to report.
37 reports arrived in the 12 months to August 2026, up 95% from 19 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (76.8%), death (14.7%) and malfunction (8.4%); across all tubes, gastrointestinal (and accessories) reports (product code KNT) death is recorded in 2.4% and malfunction in 47%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are malposition of device (72.6%), insufficient device problem information (2.6%) and difficult or delayed positioning (1.1%). The patient problems coded most often are pneumothorax, appropriate clinical signs, symptoms and conditions term/code not available and death. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,205 reports carrying product code KNT. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Malposition of device | 138 | 72.6% | 2% |
| Insufficient device problem information | 5 | 2.6% | 3.7% |
| Difficult or delayed positioning | 2 | 1.1% | 0% |
| Activation, positioning or separation problem | 1 | 0.5% | 0% |
| Breakthe device broke | 1 | 0.5% | 7.5% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.5% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.5% | 4% |
| Display difficult to read | 1 | 0.5% | 0% |
| Inadequate or insufficient training | 1 | 0.5% | 0% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.5% | 0% |
| Material puncture/hole | 1 | 0.5% | 1.3% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.5% | 0.3% |
| Physical resistance/sticking | 1 | 0.5% | 0.2% |
| Positioning problem | 1 | 0.5% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Pneumothoraxa collapsed lung | 102 | 53.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 15 | 7.9% |
| Deaththe patient died; cause not stated by this term | 8 | 4.2% |
| Low oxygen saturation | 6 | 3.2% |
| Coughcough | 4 | 2.1% |
| Pneumonialung infection | 4 | 2.1% |
| Cardiac arrestthe heart stopped | 3 | 1.6% |
| Perforation | 3 | 1.6% |
| Perforation of esophagus | 3 | 1.6% |
| Bowel perforation | 2 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 1.1% |
| Hemothorax | 2 | 1.1% |
| Pleural effusionfluid around the lung | 2 | 1.1% |
| Respiratory failurethe lungs could not supply enough oxygen | 2 | 1.1% |
| Upper respiratory tract injury | 2 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CORTRAK 2 Enteral Access System | Product code KNT | All MAUDE reports |
|---|---|---|---|
| Reports | 190 | 26,205 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 147 | 24 | 9 |
| Classified as injury | 76.8% | 49% | 36.2% |
| Classified as malfunction | 8.4% | 47% | 62.3% |
| Filed by the manufacturer | 96.8% | 91% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code KNT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Duodopa Duopa | 5,925 | 484 | 2% |
| Abbvie Peg | 1,633 | 0 | 1.7% |
| Bard DigniShield Stool Management System | 750 | 94 | 0.7% |
| Kangaroo | 4,328 | 117 | 0.2% |
| EndoVive Safety PEG Kit | 650 | 23 | 0.8% |
| EndoVive Standard PEG Kit | 534 | 15 | 2.1% |
| Corflo Cubby Low Profile Gastrostomy Device | 440 | 0 | 0% |
| Tube Gastrointestinal And Access | 448 | 0 | 1.1% |
| Endovive Jejunal Feeding Tube | 422 | 0 | 0.2% |
| Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit | 333 | 0 | 0.9% |
| Endovive Securi-T | 264 | 0 | 0.4% |
| Abbvie J | 263 | 0 | 6.8% |
| Endovive Two-Port Ttp Jejunal Feeding Tube Cap | 262 | 0 | 1.5% |
| Flexi-Seal Fms | 195 | 0 | 1.5% |
| Replacement Tube | 183 | 0 | 0.5% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about CORTRAK 2 Enteral Access System reports
How many FDA reports name CORTRAK 2 Enteral Access System?
190 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 37 in the latest 12 months.
What kinds of events are reported?
injury (76.8%), death (14.7%) and malfunction (8.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
malposition of device (72.6%), insufficient device problem information (2.6%), difficult or delayed positioning (1.1%), activation, positioning or separation problem (0.5%) and break (0.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.8%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CORTRAK 2 Enteral Access System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.