Catheter, urethral: medical device reports filed with FDA

2,608 reports carry this product code, 1994–2026; 17 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.

2,608
reports with this product code: 0% of all MAUDE reports; 452
reports, 12 months to August 2026: 286 in the 12 months before; 73.2%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code GBM is FDA's classification for "Catheter, urethral" (gastroenterology, Urology panel), a class 2 device. 2,608 medical device reports carry this product code, 0% of the MAUDE database, from January 1994 to August 2026.

452 reports arrived in the 12 months to August 2026, up 58% from 286 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 (73.2%), injury (26.3%) and other (0.2%). 17 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
Gentlecath Glide	652	73	0%	95.4%
Bardex All-Silicone Foley Catheter	440	196	0%	89.2%
Gentlecath Air	170	136	0%	95.9%
Gentlecath	158	399	0%	94.5%
L3c3850 - Gentlecath	53	0	0%	96%
Bardia All-Silicone Foley Catheter	11	8	0%	85.2%
Cure Products	10	1	0%	80.3%
McKesson Brands	8	75	0%	83.1%
Apogee	3	3	0.4%	0.8%
Gentlecath Other	3	0	0%	98%
L3c0600 - Cure Products	3	0	0%	88.4%
Dover	2	32	0.6%	87.7%
Rusch	2	0	1.8%	89.8%
Brillant 2-W Silicone Foley Cylindrical	1	0	0%	99.2%
Cure Catheter	1	107	0%	47.2%
Sensica Uo System	1	1	0%	98.4%
Surestep	1	0	0.1%	95.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Unomedical S R O	1,103	42.3%
Coloplast A/S	206	7.9%
Convatec	62	2.4%
Mentor - Minnesota Division	58	2.2%
Teleflex Medical Sdn Bhd	36	1.4%
C R Bard	29	1.1%
Bard	6	0.2%
Medivance 1725056	1	0%
Mentor	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

Death0.2%4

Injury26.3%687

Malfunction73.2%1,910

Other0.2%6

Not given0%1

Who filed

Manufacturer report92%2,399

Voluntary report1.6%42

User facility report0%0

Distributor report5.2%136

Not given1.2%31

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

Device problems coded

Device problem (FDA code)	Reports	Share
Tear, rip or hole in device packaging	341	13.1%
Device misassembled during manufacturing /shipping	244	9.4%
Difficult to removethe device was hard to remove	215	8.2%
Sharp edges	116	4.4%
Unsealed device packaging	115	4.4%
Breakthe device broke	97	3.7%
Difficult to open or remove packaging material	75	2.9%
Material puncture/hole	74	2.8%
Insufficient device problem information	59	2.3%
Delivered as unsterile product	56	2.1%
Tip breakage	56	2.1%
Deflation problem	52	2%
Patient device interaction problem	52	2%
Cut in material	50	1.9%
Fluid/blood leak	47	1.8%
Difficult to insertthe device was hard to insert	44	1.7%
Material invagination	37	1.4%
Material rupture	37	1.4%
Biocompatibility	34	1.3%
Packaging problem	32	1.2%

Questions about catheter, urethral reports

What is product code GBM?

FDA's classification code for "Catheter, urethral", 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?

2,608 reports through August 2026, 452 of them in the latest 12 months.

Which brands appear most often?

Gentlecath Glide (652), Bardex All-Silicone Foley Catheter (440), Gentlecath Air (170), Gentlecath (158) and L3c3850 - Gentlecath (53). 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.