Tubes, gastrointestinal (and accessories): medical device reports filed with FDA

26,205 reports carry this product code, 1992–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

26,205
reports with this product code: 0.1% of all MAUDE reports; 1,911
reports, 12 months to August 2026: 1,426 in the 12 months before; 47%
classified as malfunction: 62.3% across all reports; 2.4%
classified as death, as reported: 0.9% across all reports

Product code KNT is FDA's classification for "Tubes, gastrointestinal (and accessories)" (gastroenterology, Urology panel), a class 2 device. 26,205 medical device reports carry this product code, 0.1% of the MAUDE database, from February 1992 to August 2026.

1,911 reports arrived in the 12 months to August 2026, up 34% from 1,426 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 (49%), malfunction (47%) and death (2.4%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Duodopa Duopa	5,925	484	2%	0%
Abbvie Peg	1,633	0	1.7%	0%
Bard DigniShield Stool Management System	750	94	0.7%	84.9%
Kangaroo	686	117	0.2%	97%
EndoVive Safety PEG Kit	547	23	0.8%	81.4%
EndoVive Standard PEG Kit	494	15	2.1%	56%
Corflo Cubby Low Profile Gastrostomy Device	440	0	0%	99.1%
Tube Gastrointestinal And Access	433	0	1.1%	59.2%
Endovive Jejunal Feeding Tube	406	0	0.2%	66.4%
Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit	303	0	0.9%	55.9%
Endovive Securi-T	264	0	0.4%	59.8%
Abbvie J	263	0	6.8%	0%
Endovive Two-Port Ttp Jejunal Feeding Tube Cap	262	0	1.5%	42.4%
CORTRAK 2 Enteral Access System	190	37	14.7%	8.4%
Flexi-Seal Fms	180	0	1.5%	29.7%
Replacement Tube	180	0	0.5%	88.5%
CORFLO Nasogastric/Nasointestinal Feeding Tube with Stylet with ENFit Connector	171	96	0%	95.1%
Flexi-Seal Signal Fms	170	0	5.9%	48.8%
Epump 1000ml Safety Screw Spik	98	0	0%	100%
Avanos	77	38	1.2%	91.2%
Cardinal Health	61	185	0.2%	89.8%
Maintenance Unit	45	76	0%	99.8%
Covidien	35	30	1.4%	45.5%
Halyard	35	11	1.3%	94.9%
Kangaroo Joey Pump W/Pole Clmp	35	0	0.4%	98.4%
Kangaroo Epump - New	18	0	0.2%	98.6%
Kangaroo Epump - Rfb	8	0	0%	99.3%
Argyle	2	60	1%	82.4%
Barrx	2	19	1.1%	41.8%
Boston Scientific	2	5	3.3%	55%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Abbvie - Medical Device Center	6,498	24.8%
Avanos Medical	2,649	10.1%
Boston Scientific - Spencer	1,781	6.8%
Convatec	1,332	5.1%
Covidien	1,243	4.7%
Abbvie Medical Device Centre	1,071	4.1%
Cardinal Health	955	3.6%
Boston Scientific	886	3.4%
C R Bard Basd	767	2.9%
C R Bard Covington -1018233	762	2.9%
Bard Access Systems	503	1.9%
Halyard Health	480	1.8%
Boston Scientific - Marlborough	263	1%
Wilson-Cook Medical	200	0.8%
Boston Scientific - Costa Rica Coyol	156	0.6%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2.4%632

Injury49%12,836

Malfunction47%12,317

Other1%264

Not given0.6%156

Who filed

Manufacturer report91%23,852

Voluntary report3.5%924

User facility report0%0

Distributor report0.1%22

Not given5.4%1,407

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,972	7.5%
Leak/splashthe device leaked	1,234	4.7%
Detachment of device component	1,207	4.6%
Fluid/blood leak	1,184	4.5%
Difficult to removethe device was hard to remove	1,049	4%
Insufficient device problem information	962	3.7%
Detachment of device or device componentpart of the device came off	804	3.1%
Occlusion within devicethe device blocked	602	2.3%
Material rupture	525	2%
Malposition of device	522	2%
Deflation problem	518	2%
Migration or expulsion of device	510	1.9%
Material separation	461	1.8%
Replace	439	1.7%
Obstruction of flow	367	1.4%
Device dislodged or dislocated	363	1.4%
Material puncture/hole	352	1.3%
Inflation problem	337	1.3%
Device, removal of (non-implant)	309	1.2%
Explanted	283	1.1%

Questions about tubes, gastrointestinal (and accessories) reports

What is product code KNT?

FDA's classification code for "Tubes, gastrointestinal (and accessories)", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

26,205 reports through August 2026, 1,911 of them in the latest 12 months.

Which brands appear most often?

Duodopa Duopa (5,925), Abbvie Peg (1,633), Bard DigniShield Stool Management System (750), Kangaroo (686) and EndoVive Safety PEG Kit (547). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.