Catheter, intravascular, diagnostic: medical device reports filed with FDA

20,198 reports carry this product code, 1992–2026; 30 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.

20,198
reports with this product code: 0.1% of all MAUDE reports; 843
reports, 12 months to August 2026: 602 in the 12 months before; 56%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

Product code DQO is FDA's classification for "Catheter, intravascular, diagnostic" (cardiovascular panel), a class 2 device. 20,198 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1992 to August 2026.

843 reports arrived in the 12 months to August 2026, up 40% from 602 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 (56%), injury (37.6%) and other (3.1%). 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Merit Custom Kit	1,062	13	0.1%	96.7%
Ultrasonic Imaging Catheter - Coronary	569	0	0%	98.6%
Trapease Pvcf Fem/Jug 55cm Csi	283	0	3.7%	0%
466p306x	263	0	1.8%	1.8%
Renegade	260	0	0.3%	95.7%
Infiniti	259	141	0%	92.1%
Tempo	246	155	0.7%	58.3%
Impress Braided Catheter	215	0	0%	16.7%
Impress	200	25	1%	27.5%
Impress Peripheral Catheter	186	0	0%	36.6%
Dragonfly OpStar	183	88	0.5%	83.4%
V-Cath	146	0	1.7%	14.3%
Arrow	126	65	3.4%	66.7%
Bard	123	2	1.8%	31.1%
Trapease Filter	120	0	13.9%	11.5%
Guide Wires	104	0	1.6%	55.1%
Groshong Catheter	85	58	1.9%	47.1%
Cook	55	6	2.2%	45%
Unknown Trapease Vena Cava Filter	35	0	1.9%	0%
Vista Brite Tip	25	67	0%	94.3%
First Picc Peripherally Inserted Central Catheter	19	0	1.8%	0%
First Picc	18	0	0.4%	72.8%
Cordis	17	0	9.3%	20.6%
Flexima?	16	10	0.4%	75.5%
Ra Cath Set 20 Ga X 1-3/4	15	0	0%	77.7%
Catheter	13	9	3.7%	27.9%
Unknown Vena Cava Filter	11	0	3.3%	5.2%
Acuson	10	0	0.4%	92.9%
OptiCross	10	136	0.9%	87.2%
Premicath	10	54	3.6%	69.8%

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
Merit Medical Systems	2,143	10.6%
Bard Access Systems	1,776	8.8%
Cook	916	4.5%
Arrow International	857	4.2%
Arrow Intl	800	4%
Cordis	704	3.5%
Cordis Cashel	682	3.4%
Cordis De Mexico	643	3.2%
Cordis US	602	3%
Boston Scientific - Fremont Sud	505	2.5%
Angiodynamics	356	1.8%
Boston Scientific - Costa Rica Coyol	320	1.6%
C R Bard Basd	249	1.2%
Terumo Ashitaka	246	1.2%
Mallinckrodt Medical	209	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

Death2.2%446

Injury37.6%7,588

Malfunction56%11,301

Other3.1%630

Not given1.2%233

Who filed

Manufacturer report82.1%16,573

Voluntary report7.6%1,543

User facility report0%0

Distributor report0.4%84

Not given9.9%1,998

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	2,793	13.8%
Material separation	1,973	9.8%
Difficult to removethe device was hard to remove	1,748	8.7%
Fracturea broken bone	1,581	7.8%
Leak/splashthe device leaked	1,256	6.2%
Implant, removal of	1,181	5.8%
Replace	1,111	5.5%
Explanted	969	4.8%
Detachment of device component	771	3.8%
Retraction problem	720	3.6%
Difficult to insertthe device was hard to insert	711	3.5%
Tip breakage	677	3.4%
Crackthe device cracked	676	3.3%
Migration or expulsion of device	636	3.1%
Device, removal of (non-implant)	628	3.1%
Detachment of device or device componentpart of the device came off	610	3%
Device contamination with chemical or other material	575	2.8%
Fluid/blood leak	504	2.5%
Device, or device fragments remain in patient	484	2.4%
Kinkedthe tube or line kinked	461	2.3%

Questions about catheter, intravascular, diagnostic reports

What is product code DQO?

FDA's classification code for "Catheter, intravascular, diagnostic", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

20,198 reports through August 2026, 843 of them in the latest 12 months.

Which brands appear most often?

Merit Custom Kit (1,062), Ultrasonic Imaging Catheter - Coronary (569), Trapease Pvcf Fem/Jug 55cm Csi (283), 466p306x (263) and Renegade (260). 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.