Dilator, esophageal: medical device reports filed with FDA

5,261 reports carry this product code, 1993–2026; 15 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.

5,261
reports with this product code: 0% of all MAUDE reports; 364
reports, 12 months to August 2026: 249 in the 12 months before; 90.6%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code KNQ is FDA's classification for "Dilator, esophageal" (gastroenterology, Urology panel), a class 2 device. 5,261 medical device reports carry this product code, 0% of the MAUDE database, from April 1993 to August 2026.

364 reports arrived in the 12 months to August 2026, up 46% from 249 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 malfunction (90.6%), injury (8.6%) and death (0.3%). 15 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
CRE Fixed Wire	952	152	0%	96.1%
Hercules 3 Stage Wireguided Balloon Esophageal-Pyloric-Colonic	643	46	0%	96.6%
Xxl Esophageal	633	14	0.2%	92.3%
Hercules 3 Stage Balloon Esophageal	454	7	0%	94.3%
Cre Pro Gi	340	62	0%	98%
CRE Wireguided	246	56	0.3%	93.2%
Quantum Ttc Esophageal Balloon Dilator	218	0	0%	98.2%
Cre Balloon Dilatation Catheter	128	0	0%	90.3%
XXL? Vascular	60	8	0.9%	77.7%
Captura Serrated Forceps With Spike	3	0	0%	87.4%
Amplatz Super Stiff Guidewire	1	0	3%	80.1%
Balloon	1	48	0.3%	71.5%
Boston Scientific	1	5	3.3%	55%
Conmed	1	89	0.2%	65.6%
Cre Pro	1	341	0.1%	97.9%

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
Wilson-Cook Medical	825	15.7%
Cook Endoscopy	681	12.9%
Boston Scientific - Cork	388	7.4%
Boston Scientific - Galway	188	3.6%
Gyrus Acmi	141	2.7%
Boston Scientific Ireland	46	0.9%
Conmed	41	0.8%
Cordis Cashel	41	0.8%
Consolidated Medical Equipment	32	0.6%
Cordis Europa	24	0.5%
Boston Scientific - Marlborough	18	0.3%
Cordis De Mexico	7	0.1%
Boston Scientific	3	0.1%
Bard	1	0%
Ethicon Endo Surgery	1	0%

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

Death0.3%16

Injury8.6%455

Malfunction90.6%4,769

Other0.3%14

Not given0.1%7

Who filed

Manufacturer report95.1%5,001

Voluntary report2.2%117

User facility report0%0

Distributor report0%2

Not given2.7%141

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

Device problems coded

Device problem (FDA code)	Reports	Share
Burst container or vessel	1,092	20.8%
Material rupture	854	16.2%
Material puncture/hole	404	7.7%
Deflation problem	362	6.9%
Leak/splashthe device leaked	340	6.5%
Fluid/blood leak	285	5.4%
Inflation problem	255	4.8%
Difficult to removethe device was hard to remove	230	4.4%
Hole in material	230	4.4%
Fracturea broken bone	187	3.6%
Breakthe device broke	165	3.1%
Detachment of device component	152	2.9%
Balloon rupture	134	2.5%
Crackthe device cracked	134	2.5%
Balloon burst	130	2.5%
Failure to deflate	124	2.4%
Detachment of device or device componentpart of the device came off	86	1.6%
Material deformation	78	1.5%
Bent	59	1.1%
Off-label use	54	1%

Questions about dilator, esophageal reports

What is product code KNQ?

FDA's classification code for "Dilator, esophageal", 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?

5,261 reports through August 2026, 364 of them in the latest 12 months.

Which brands appear most often?

CRE Fixed Wire (952), Hercules 3 Stage Wireguided Balloon Esophageal-Pyloric-Colonic (643), Xxl Esophageal (633), Hercules 3 Stage Balloon Esophageal (454) and Cre Pro Gi (340). 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.