Prosthesis, esophageal: medical device reports filed with FDA

3,101 reports carry this product code, 1995–2026; 13 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.

3,101
reports with this product code: 0% of all MAUDE reports; 104
reports, 12 months to August 2026: 140 in the 12 months before; 49%
classified as malfunction: 62.3% across all reports; 4.2%
classified as death, as reported: 0.9% across all reports

Product code ESW is FDA's classification for "Prosthesis, esophageal" (general, Plastic Surgery panel), a class 2 device. 3,101 medical device reports carry this product code, 0% of the MAUDE database, from September 1995 to August 2026.

104 reports arrived in the 12 months to August 2026, down 26% from 140 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 (49%), injury (46.2%) and death (4.2%). 13 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
Ultraflex Esophageal NG	578	26	1.2%	65.7%
WallFlex? Esophageal	494	12	6.1%	29.5%
Niti-S Esophageal Covered Stent	178	4	2.2%	87.1%
Ultraflex	167	0	4.5%	38.9%
Evolution Esophageal Controlled-Release Stent - Partially Covered	155	6	0.6%	59%
Ultraflex Tracheobronchial	23	51	0.3%	59.5%
Evolution Biliary Controlled-Release Stent - Fully Covered	13	99	0.2%	83.7%
Fluency Plus Tracheobronchial Stent Graft	7	0	0%	90.7%
Rusch	2	0	1.8%	89.8%
Boston Scientific	1	5	3.3%	55%
Insulin Infusion Pump	1	0	2.6%	43.9%
Interstim	1	1,522	0.2%	50.2%
Wallstent Biliary	1	5	0.6%	72.7%

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
Boston Scientific - Galway	983	31.7%
Cook Ireland	418	13.5%
Boston Scientific Ireland	139	4.5%
Merit Medical Systems	48	1.5%
Boston Scientific - Marlborough	33	1.1%
Wilson-Cook Medical	31	1%
Cook Endoscopy	18	0.6%
American Heyer-Schulte	4	0.1%
Angiomed & Medizintechnik Kg	2	0.1%
Mdt Puerto Rico Operations Juncos	1	0%
Medtronic Puerto Rico Operations	1	0%
William Cook Europe	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

Death4.2%131

Injury46.2%1,432

Malfunction49%1,520

Other0.4%12

Not given0.2%6

Who filed

Manufacturer report95.8%2,971

Voluntary report1%32

User facility report0%0

Distributor report2%63

Not given1.1%35

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

Device problems coded

Device problem (FDA code)	Reports	Share
Activation, positioning or separation problem	566	18.3%
Migration or expulsion of device	412	13.3%
Activation failure	256	8.3%
Breakthe device broke	252	8.1%
Positioning failure	203	6.5%
Migrationthe device moved from where it was placed	184	5.9%
Positioning problem	176	5.7%
Difficult to removethe device was hard to remove	163	5.3%
Other (for use when an appropriate device code cannot be identified)	109	3.5%
Material deformation	106	3.4%
Detachment of device or device componentpart of the device came off	92	3%
Material integrity problema problem with the device material	91	2.9%
Partial blockage	88	2.8%
Activation problem	78	2.5%
Replace	77	2.5%
Fracturea broken bone	72	2.3%
Improper or incorrect procedure or method	60	1.9%
Explanted	55	1.8%
Device remains implanted	53	1.7%
Failure to advance	52	1.7%

Questions about prosthesis, esophageal reports

What is product code ESW?

FDA's classification code for "Prosthesis, esophageal", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,101 reports through August 2026, 104 of them in the latest 12 months.

Which brands appear most often?

Ultraflex Esophageal NG (578), WallFlex? Esophageal (494), Niti-S Esophageal Covered Stent (178), Ultraflex (167) and Evolution Esophageal Controlled-Release Stent - Partially Covered (155). 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.