Stent, ureteral: medical device reports filed with FDA

5,909 reports carry this product code, 1993–2026; 22 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.

5,909
reports with this product code: 0% of all MAUDE reports; 616
reports, 12 months to August 2026: 652 in the 12 months before; 70.6%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code FAD is FDA's classification for "Stent, ureteral" (gastroenterology, Urology panel), a class 2 device. 5,909 medical device reports carry this product code, 0% of the MAUDE database, from September 1993 to August 2026.

616 reports arrived in the 12 months to August 2026, close to the 652 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 (70.6%), injury (28.5%) and other (0.5%). 22 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
Polaris? Ultra	478	49	0%	83.1%
Bard InLay Optima Ureteral Stent	394	44	0%	79.2%
Bard InLay Ureteral Stent with HydroGlide Guidewire	342	17	0%	86.5%
Percuflex Plus	301	50	0.4%	67.2%
Resonance Stent Set	256	16	1.2%	21.1%
Bard InLay Ureteral Stent	232	25	0%	69.8%
Filiform Double Pigtail Ureteral Stent Set	225	38	0.4%	81.1%
Bard InLay Optima Ureteral Stent with HydroGlide Guidewire	220	14	0%	88.6%
Universa Soft Ureteral Stent Set	204	14	0%	73.7%
Universa Firm Ureteral Stent Set	203	12	0%	61.1%
Contour	157	38	0%	85.3%
Polaris? Loop	154	25	0.6%	93.5%
Flexima?	20	10	0.4%	75.5%
Boston Scientific	4	5	3.3%	55%
Cotton-Leung Biliary Stent	3	20	1.1%	55.7%
Cook	2	6	2.2%	45%
Bard	1	2	1.8%	31.1%
Bardex Foley Catheter Silicone Coated	1	306	0.1%	93.9%
Evolution Biliary Controlled-Release Stent - Fully Covered	1	99	0.2%	83.7%
Evolution Duodenal Controlled-Release Stent - Uncovered	1	5	0.5%	52.7%
Olympus	1	9	2.5%	69.7%
Zimmon Pancreatic Stent	1	6	0%	85.3%

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
C R Bard Covington -1018233	1,393	23.6%
Cook	667	11.3%
Boston Scientific - Costa Rica Coyol	295	5%
Cook Ireland	288	4.9%
Coloplast A/S	197	3.3%
Productos Para El Cuidado De La Salud -9611590	60	1%
C R Bard	43	0.7%
Boston Scientific - Costa Rica	21	0.4%
Applied Medical	15	0.3%
Applied Medical Resources	14	0.2%
Teleflex Medical	11	0.2%
Gyrus Acmi	9	0.2%
Boston Scientific	5	0.1%
American Medical Systems	4	0.1%
Angiomed & Medizintechnik Kg	4	0.1%

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

Death0.2%9

Injury28.5%1,686

Malfunction70.6%4,171

Other0.5%30

Not given0.2%13

Who filed

Manufacturer report94.5%5,583

Voluntary report2.1%123

User facility report0%0

Distributor report0.7%44

Not given2.7%159

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,427	24.1%
Material fragmentation	595	10.1%
Calcified	472	8%
Difficult to removethe device was hard to remove	404	6.8%
Material separation	246	4.2%
Material split, cut or torn	232	3.9%
Difficult to advance	213	3.6%
Detachment of device or device componentpart of the device came off	212	3.6%
Material deformation	200	3.4%
Migrationthe device moved from where it was placed	171	2.9%
Deformation due to compressive stress	168	2.8%
Patient device interaction problem	128	2.2%
Fracturea broken bone	125	2.1%
Biocompatibility	99	1.7%
Detachment of device component	97	1.6%
Migration or expulsion of device	94	1.6%
Replace	87	1.5%
Device damaged prior to usethe device was damaged before use	74	1.3%
Torn material	74	1.3%
Nonstandard device	70	1.2%

Questions about stent, ureteral reports

What is product code FAD?

FDA's classification code for "Stent, ureteral", 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?

5,909 reports through August 2026, 616 of them in the latest 12 months.

Which brands appear most often?

Polaris? Ultra (478), Bard InLay Optima Ureteral Stent (394), Bard InLay Ureteral Stent with HydroGlide Guidewire (342), Percuflex Plus (301) and Resonance Stent Set (256). 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.