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FDA product code FGE · class 2 · Gastroenterology, Urology
Stents, drains and dilators for the biliary ducts: medical device reports filed with FDA
33,832 reports carry this product code, 1993–2026; 30 brands with a page.
- 33,832
- reports with this product code
- 0.1% of all MAUDE reports
- 1,971
- reports, 12 months to August 2026
- 1,991 in the 12 months before
- 69%
- classified as malfunction
- 62.3% across all reports
- 1.1%
- classified as death, as reported
- 0.9% across all reports
Product code FGE is FDA's classification for "Stents, drains and dilators for the biliary ducts" (gastroenterology, Urology panel), a class 2 device. 33,832 medical device reports carry this product code, 0.1% of the MAUDE database, from August 1993 to August 2026.
1,971 reports arrived in the 12 months to August 2026, close to the 1,991 of 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 (69%), injury (29%) and death (1.1%). 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
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 | 5,134 | 15.2% |
| Boston Scientific - Galway | 3,921 | 11.6% |
| Cook Ireland | 3,920 | 11.6% |
| Boston Scientific - Spencer | 1,344 | 4% |
| Cordis De Mexico | 1,110 | 3.3% |
| Cordis | 944 | 2.8% |
| Boston Scientific - Cork | 587 | 1.7% |
| Ev3 | 584 | 1.7% |
| Cook | 579 | 1.7% |
| Av-Temecula-Ct | 559 | 1.7% |
| Cordis Europa | 473 | 1.4% |
| Boston Scientific - Costa Rica Coyol | 428 | 1.3% |
| Boston Scientific - Maple Grove | 393 | 1.2% |
| Covidien | 352 | 1% |
| Abbott Vascular-Vascular Solutions | 295 | 0.9% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Material rupture | 4,890 | 14.5% |
| Breakthe device broke | 3,293 | 9.7% |
| Difficult to removethe device was hard to remove | 1,964 | 5.8% |
| Improper or incorrect procedure or method | 1,365 | 4% |
| Positioning failure | 1,343 | 4% |
| Premature activation | 1,334 | 3.9% |
| Material deformation | 1,321 | 3.9% |
| Device dislodged or dislocated | 1,280 | 3.8% |
| Detachment of device or device componentpart of the device came off | 1,122 | 3.3% |
| Migration or expulsion of device | 1,109 | 3.3% |
| Burst container or vessel | 1,105 | 3.3% |
| Fracturea broken bone | 1,061 | 3.1% |
| Activation, positioning or separation problem | 1,037 | 3.1% |
| Material puncture/hole | 1,000 | 3% |
| Difficult or delayed positioning | 908 | 2.7% |
| Detachment of device component | 891 | 2.6% |
| Replace | 800 | 2.4% |
| Failure to advance | 761 | 2.2% |
| Device remains implanted | 700 | 2.1% |
| Occlusion within devicethe device blocked | 647 | 1.9% |
Questions about stents, drains and dilators for the biliary ducts reports
What is product code FGE?
FDA's classification code for "Stents, drains and dilators for the biliary ducts", 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?
33,832 reports through August 2026, 1,971 of them in the latest 12 months.
Which brands appear most often?
Mustang (5,243), Hurricane RX (1,227), Cre Pro (984), Advanix Biliary (872) and WallFlex Biliary RX Stent System (774). 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.