Catheter, continuous flush: medical device reports filed with FDA

9,056 reports carry this product code, 1992–2026; 23 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.

9,056
reports with this product code: 0% of all MAUDE reports; 813
reports, 12 months to August 2026: 1,193 in the 12 months before; 74.2%
classified as malfunction: 62.3% across all reports; 4%
classified as death, as reported: 0.9% across all reports

Product code KRA is FDA's classification for "Catheter, continuous flush" (cardiovascular panel), a class 2 device. 9,056 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

813 reports arrived in the 12 months to August 2026, down 32% from 1,193 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 (74.2%), injury (20.9%) and death (4%). 23 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
Echelon	711	584	3.2%	72.8%
Marathon	486	66	5.9%	54.9%
Rebar	456	108	9%	62.8%
Prowler Select Microcatheters	452	0	1.5%	88.1%
Cxi Support Catheter	406	23	0%	79.7%
Marksman	405	77	6.7%	63%
Prowler Select Plus 150/5cm	398	1	0.2%	96.5%
Cathera	321	0	7.3%	66.1%
Renegade? HI-FLO? Kit	266	15	0%	96.6%
Prowler Select	185	461	0.1%	98.5%
Direxion?	151	23	0%	89.4%
Marathon Micro Catheter	150	0	2.3%	35.5%
Renegade? HI-FLO? FATHOM? System	150	11	0%	96%
AngioJet SOLENT Proxi	142	5	4.6%	84.6%
AngioJet SOLENT omni	61	26	1.3%	93.1%
Angiojet Zelantedvt	56	0	5.3%	76.3%
Phenom Catheter	41	406	3.1%	80.6%
Renegade	35	0	0.3%	95.7%
Swan-Ganz Ccombo V	4	88	0.6%	97%
Onyx	1	69	13.4%	12%
Onyx Avm	1	27	4.9%	21.7%
Performer Introducer	1	15	1.3%	79.5%
Rist	1	53	3%	47%

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
Micro Therapeutics Ev3	1,855	20.5%
Medos International Sarl	667	7.4%
Cordis Neurovascular	548	6.1%
Boston Scientific - Cork	480	5.3%
Covidien Irvine	356	3.9%
Ev3 Neurovascular	305	3.4%
Codman And Shurtleff	270	3%
Covidien	268	3%
Medtronic Dominicana	260	2.9%
Medtronic Mexico S De R L De Cv	154	1.7%
Cook	113	1.2%
Merit Medical Systems	93	1%
Edwards Lifesciences Pr	92	1%
Boston Scientific - Maple Grove	65	0.7%
Icu Medical De Mexico S De R L De C V	49	0.5%

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

Death4%362

Injury20.9%1,895

Malfunction74.2%6,724

Other0.3%31

Not given0.5%44

Who filed

Manufacturer report97.1%8,791

Voluntary report0.9%81

User facility report0%0

Distributor report0.1%5

Not given2%179

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

Device problems coded

Device problem (FDA code)	Reports	Share
Physical resistance/sticking	1,519	16.8%
Breakthe device broke	1,506	16.6%
Leak/splashthe device leaked	477	5.3%
Material deformation	358	4%
Material separation	357	3.9%
Fracturea broken bone	332	3.7%
Difficult to removethe device was hard to remove	316	3.5%
Detachment of device or device componentpart of the device came off	290	3.2%
Physical resistance	283	3.1%
Obstruction of flow	269	3%
Burst container or vessel	263	2.9%
Material rupture	249	2.7%
Entrapment of device	211	2.3%
Detachment of device component	192	2.1%
Difficult to advance	173	1.9%
Device dislodged or dislocated	168	1.9%
Device damaged by another device	158	1.7%
Fluid/blood leak	157	1.7%
Material integrity problema problem with the device material	146	1.6%
Retraction problem	109	1.2%

Questions about catheter, continuous flush reports

What is product code KRA?

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

How many reports carry this code?

9,056 reports through August 2026, 813 of them in the latest 12 months.

Which brands appear most often?

Echelon (711), Marathon (486), Rebar (456), Prowler Select Microcatheters (452) and Cxi Support Catheter (406). 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.