Devices › Prosthesis, esophageal
Device brand name · Prosthesis esophageal
Ultraflex: medical device reports filed with FDA
198 reports name it, 1997–2015. Manufacturer given most often on reports: Boston Scientific - Galway. Product code ESW.
- 198
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 38.9%
- classified as malfunction
- 49% across the product code
- 4.5%
- classified as death, as reported
- 9 reports · not verified by FDA
198 medical device reports received by FDA name the brand "Ultraflex" (prosthesis esophageal); the manufacturer given most often on reports is Boston Scientific - Galway; received from March 1997 to October 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (56.1%), malfunction (38.9%) and death (4.5%); across all prosthesis, esophageal reports (product code ESW) death is recorded in 4.2% and malfunction in 49%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are partial blockage (14.1%), migration or expulsion of device (12.6%) and break (5.1%). The patient problems coded most often are dysphagia/ odynophagia, therapy/non-surgical treatment, additional 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
No report naming Ultraflex was received in the five years to August 2026; the latest was received in October 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,101 reports carrying product code ESW. 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 |
|---|---|---|---|
| Partial blockage | 28 | 14.1% | 2.8% |
| Migration or expulsion of device | 25 | 12.6% | 13.3% |
| Breakthe device broke | 10 | 5.1% | 8.1% |
| Occlusion within devicethe device blocked | 8 | 4% | 0.9% |
| Activation, positioning or separation problem | 7 | 3.5% | 18.3% |
| Positioning problem | 5 | 2.5% | 5.7% |
| Replace | 5 | 2.5% | 2.5% |
| Suture line separation | 3 | 1.5% | 1% |
| Failure to unfold or unwrap | 2 | 1% | 0.1% |
| Bent | 1 | 0.5% | 0.3% |
| Component missing | 1 | 0.5% | 0.5% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.5% | 0.8% |
| Device, removal of (non-implant) | 1 | 0.5% | 1% |
| Difficult or delayed positioning | 1 | 0.5% | 1.5% |
| Difficult to insertthe device was hard to insert | 1 | 0.5% | 0.4% |
| Difficult to position | 1 | 0.5% | 1.2% |
| Difficult to removethe device was hard to remove | 1 | 0.5% | 5.3% |
| Dislodged | 1 | 0.5% | 0.4% |
| Explanted | 1 | 0.5% | 1.8% |
| Failure to advance | 1 | 0.5% | 1.7% |
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 |
|---|---|---|
| Dysphagia/ odynophagia | 19 | 9.6% |
| Therapy/non-surgical treatment, additional | 9 | 4.5% |
| Deaththe patient died; cause not stated by this term | 5 | 2.5% |
| Dyspneashortness of breath | 5 | 2.5% |
| Blood loss | 3 | 1.5% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.5% |
| Blockage | 2 | 1% |
| Chest painchest pain | 2 | 1% |
| Device embedded in tissue or plaque | 2 | 1% |
| Hemorrhage/blood loss/bleeding | 2 | 1% |
| Aspiration/inhalation | 1 | 0.5% |
| Breathing difficulties | 1 | 0.5% |
| Chokingchoking | 1 | 0.5% |
| Contraindicated patient | 1 | 0.5% |
| Hospitalization required | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ultraflex | Product code ESW | All MAUDE reports |
|---|---|---|---|
| Reports | 198 | 3,101 | 26,136,888 |
| Share of that pool | — | 6.4% | 0% |
| Classified as death, per 1,000 reports | 45 | 42 | 9 |
| Classified as injury | 56.1% | 46.2% | 36.2% |
| Classified as malfunction | 38.9% | 49% | 62.3% |
| Filed by the manufacturer | 95.5% | 95.8% | 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 ESW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ultraflex Esophageal NG | 578 | 26 | 1.2% |
| WallFlex? Esophageal | 495 | 12 | 6.1% |
| Niti-S Esophageal Covered Stent | 178 | 4 | 2.2% |
| Evolution Esophageal Controlled-Release Stent - Partially Covered | 156 | 6 | 0.6% |
| Ultraflex Tracheobronchial | 713 | 51 | 0.3% |
| Evolution Biliary Controlled-Release Stent - Fully Covered | 600 | 99 | 0.2% |
| Fluency Plus Tracheobronchial Stent Graft | 323 | 0 | 0% |
| Rusch | 285 | 0 | 1.8% |
| Boston Scientific | 580 | 5 | 3.3% |
| Insulin Infusion Pump | 5,096 | 0 | 2.6% |
| Interstim | 11,298 | 1,522 | 0.2% |
| Wallstent Biliary | 161 | 5 | 0.6% |
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 Ultraflex reports
How many FDA reports name Ultraflex?
198 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (56.1%), malfunction (38.9%) and death (4.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
partial blockage (14.1%), migration or expulsion of device (12.6%), break (5.1%), occlusion within device (4%) and activation, positioning or separation problem (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ultraflex 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.