Catheter, intravascular occluding, temporary: medical device reports filed with FDA

2,348 reports carry this product code, 1999–2026; 6 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.

2,348
reports with this product code: 0% of all MAUDE reports; 206
reports, 12 months to August 2026: 205 in the 12 months before; 75.4%
classified as malfunction: 62.3% across all reports; 4.3%
classified as death, as reported: 0.9% across all reports

Product code MJN is FDA's classification for "Catheter, intravascular occluding, temporary" (cardiovascular panel), a class 2 device. 2,348 medical device reports carry this product code, 0% of the MAUDE database, from May 1999 to August 2026.

206 reports arrived in the 12 months to August 2026, close to the 205 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 (75.4%), injury (19.5%) and death (4.3%). 6 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
Pruitt F3 Carotid Shunt	372	73	0.3%	92.9%
Micrus Microcoil System	87	0	5.4%	46.1%
GORE Molding & Occlusion Balloon Catheter	73	30	5.5%	4.8%
Equalizer	56	2	0%	92.6%
Balloon	2	48	0.3%	71.5%
TufTex Over-the-Wire Embolectomy Catheter	1	159	0%	99.7%

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
Lemaitre Vascular	555	23.6%
Stryker Neurovascular Cork	379	16.1%
Microvention	198	8.4%
Micro Therapeutics Ev3	183	7.8%
Ev3 Neurovascular	157	6.7%
Micrus Endovascular	122	5.2%
Spectranetics	61	2.6%
The Spectranetics	61	2.6%
W L Gore & Associates	50	2.1%
Covidien Irvine	47	2%
Edwards Lifesciences Pr	27	1.1%
Aga Medical	15	0.6%
Cook	6	0.3%
Horizon Medical Products	6	0.3%
Codman And Shurtleff	4	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

Death4.3%102

Injury19.5%457

Malfunction75.4%1,770

Other0.6%13

Not given0.3%6

Who filed

Manufacturer report96.3%2,260

Voluntary report1.4%33

User facility report0%0

Distributor report0%0

Not given2.3%55

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

Device problems coded

Device problem (FDA code)	Reports	Share
Material rupture	367	15.6%
Deflation problem	327	13.9%
Leak/splashthe device leaked	255	10.9%
Inflation problem	227	9.7%
Burst container or vessel	134	5.7%
Fluid/blood leak	125	5.3%
Breakthe device broke	85	3.6%
Material puncture/hole	68	2.9%
Difficult to removethe device was hard to remove	59	2.5%
Failure to deflate	55	2.3%
Patient device interaction problem	43	1.8%
Entrapment of device	32	1.4%
Material deformation	31	1.3%
Balloon rupture	29	1.2%
Detachment of device component	29	1.2%
Replace	29	1.2%
Failure to advance	28	1.2%
Device operates differently than expectedthe device behaved unexpectedly	27	1.1%
Stretched	27	1.1%
Hole in material	26	1.1%

Questions about catheter, intravascular occluding, temporary reports

What is product code MJN?

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

How many reports carry this code?

2,348 reports through August 2026, 206 of them in the latest 12 months.

Which brands appear most often?

Pruitt F3 Carotid Shunt (372), Micrus Microcoil System (87), GORE Molding & Occlusion Balloon Catheter (73), Equalizer (56) and Balloon (2). 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.