Catheter, percutaneous, neurovasculature: medical device reports filed with FDA

1,767 reports carry this product code, 2020–2026; 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.

1,767
reports with this product code: 0% of all MAUDE reports; 1,117
reports, 12 months to August 2026: 413 in the 12 months before; 81.7%
classified as malfunction: 62.3% across all reports; 2.8%
classified as death, as reported: 0.9% across all reports

Product code QJP is FDA's classification for "Catheter, percutaneous, neurovasculature" (cardiovascular panel), a class 2 device. 1,767 medical device reports carry this product code, 0% of the MAUDE database, from July 2020 to August 2026.

1,117 reports arrived in the 12 months to August 2026, up 170% from 413 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 (81.7%), injury (15.4%) and death (2.8%). 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
Prowler Select	559	461	0.1%	98.5%
Phenom Catheter	526	406	3.1%	80.6%
React catheter	90	41	18.4%	25.4%
Rist	70	53	3%	47%
Unknown_Neurovascular_Product	5	48	12.9%	15.3%
Prowler Select Plus 150/5cm	4	1	0.2%	96.5%

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
Medos International Sarl	682	38.6%
Medtronic Mexico S De R L De Cv	400	22.6%
Micro Therapeutics Ev3	226	12.8%
Neuravi	187	10.6%
Stryker Neurovascular-Utah-Salt Lake City	11	0.6%
Microvention	7	0.4%
Stryker Neurovascular Cork	4	0.2%
Covidien Medical Products	3	0.2%
Asahi Intecc	1	0.1%

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

Death2.8%50

Injury15.4%273

Malfunction81.7%1,444

Other0%0

Not given0%0

Who filed

Manufacturer report99.3%1,754

Voluntary report0.5%9

User facility report0%0

Distributor report0%0

Not given0.2%4

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

Device problems coded

Device problem (FDA code)	Reports	Share
Physical resistance/sticking	876	49.6%
Retraction problem	255	14.4%
Material twisted/bent	120	6.8%
Crackthe device cracked	99	5.6%
Material deformation	88	5%
Breakthe device broke	87	4.9%
Difficult to advance	86	4.9%
Unintended movement	50	2.8%
Material separation	37	2.1%
Fluid/blood leak	31	1.8%
Burst container or vessel	29	1.6%
Difficult to removethe device was hard to remove	28	1.6%
Deformation due to compressive stress	27	1.5%
Fracturea broken bone	24	1.4%
Stretched	24	1.4%
Deflation problem	15	0.8%
Device damaged by another device	15	0.8%
Packaging problem	14	0.8%
Material integrity problema problem with the device material	12	0.7%
Inflation problem	10	0.6%

Questions about catheter, percutaneous, neurovasculature reports

What is product code QJP?

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

How many reports carry this code?

1,767 reports through August 2026, 1,117 of them in the latest 12 months.

Which brands appear most often?

Prowler Select (559), Phenom Catheter (526), React catheter (90), Rist (70) and Unknown_Neurovascular_Product (5). 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.