Stylet for catheter, gastro-urology: medical device reports filed with FDA

2,451 reports carry this product code, 1992–2026; 11 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.

2,451
reports with this product code: 0% of all MAUDE reports; 132
reports, 12 months to August 2026: 135 in the 12 months before; 79.2%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

Product code EZB is FDA's classification for "Stylet for catheter, gastro-urology" (gastroenterology, Urology panel), a class 1 device. 2,451 medical device reports carry this product code, 0% of the MAUDE database, from November 1992 to August 2026.

132 reports arrived in the 12 months to August 2026, close to the 135 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 (79.2%), injury (19.6%) and death (1%). 11 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
Jagwire	789	22	0.7%	82.3%
Sensor	259	50	0.3%	59.7%
NiCore Nitinol Guidewire	201	45	0%	94%
Amplatz Super Stiff	133	50	4.7%	77.1%
Zipwire Hydrophilic Guidewire	103	0	0%	80.3%
Pathfinder	13	0	0%	66.8%
Amplatz Super Stiff Guidewire	3	0	3%	80.1%
Boston Scientific	2	5	3.3%	55%
Latex Foley Catheter	2	7	0%	81.3%
Guidewire	1	15	0.6%	77.3%
Hiwire Nitinol Hydrophilic Wire Guide	1	9	0%	78%

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 - Costa Rica Coyol	463	18.9%
Boston Scientific - Costa Rica	120	4.9%
C R Bard Covington -1018233	106	4.3%
Lake Region Medical	103	4.2%
Boston Scientific - Costa Rica Heredia	27	1.1%
Boston Scientific - Marlborough	21	0.9%
Applied Medical Resources	5	0.2%

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

Death1%24

Injury19.6%480

Malfunction79.2%1,942

Other0.1%3

Not given0.1%2

Who filed

Manufacturer report96.1%2,355

Voluntary report1.7%41

User facility report0%0

Distributor report0.2%6

Not given2%49

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

Device problems coded

Device problem (FDA code)	Reports	Share
Detachment of device component	684	27.9%
Peeled/delaminated	320	13.1%
Breakthe device broke	243	9.9%
Flaked	225	9.2%
Detachment of device or device componentpart of the device came off	173	7.1%
Device damaged by another device	76	3.1%
Material integrity problema problem with the device material	68	2.8%
Material fragmentation	66	2.7%
Device damaged prior to usethe device was damaged before use	65	2.7%
Device, or device fragments remain in patient	64	2.6%
Tip breakage	64	2.6%
Unraveled material	51	2.1%
Material protrusion/extrusion	42	1.7%
Difficult to removethe device was hard to remove	40	1.6%
Difficult to advance	36	1.5%
Material deformation	36	1.5%
Source, detachment from	34	1.4%
Difficult to insertthe device was hard to insert	31	1.3%
Other (for use when an appropriate device code cannot be identified)	30	1.2%
Wire(s), breakage of	28	1.1%

Questions about stylet for catheter, gastro-urology reports

What is product code EZB?

FDA's classification code for "Stylet for catheter, gastro-urology", class 1, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,451 reports through August 2026, 132 of them in the latest 12 months.

Which brands appear most often?

Jagwire (789), Sensor (259), NiCore Nitinol Guidewire (201), Amplatz Super Stiff (133) and Zipwire Hydrophilic Guidewire (103). 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.