Catheter, thrombus retriever: medical device reports filed with FDA

8,663 reports carry this product code, 2004–2026; 16 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.

8,663
reports with this product code: 0% of all MAUDE reports; 464
reports, 12 months to August 2026: 629 in the 12 months before; 49.1%
classified as malfunction: 62.3% across all reports; 10.4%
classified as death, as reported: 0.9% across all reports

Product code NRY is FDA's classification for "Catheter, thrombus retriever" (cardiovascular panel), a class 2 device. 8,663 medical device reports carry this product code, 0% of the MAUDE database, from September 2004 to August 2026.

464 reports arrived in the 12 months to August 2026, down 26% from 629 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 (49.1%), injury (40.1%) and death (10.4%). 16 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
Solitaire Fr4	590	49	13.9%	31%
Solitaire Fr	525	93	12.3%	56.2%
Penumbra System 3max Reperfusion Catheter	478	0	3.1%	74.4%
Penumbra System Jet7 Reperfusion Catheter	375	0	4%	81.5%
Penumbra System 5max Ace Reperfusion Catheter	343	0	0.9%	86.9%
Unknown Solitaire	310	29	37.1%	3.9%
Penumbra System Ace 68 Reperfusion Catheter	208	0	0%	84.6%
Penumbra System Reperfusion Catheter 032	184	0	9.2%	63%
Penumbra System RED 72 Reperfusion Catheter	157	18	4.4%	79.7%
Unknown_Neurovascular_Product	95	48	12.9%	15.3%
Neuron Delivery Catheter 070	3	0	0%	97.6%
Cerenovus Enterprise	1	951	0.5%	93.7%
Pipeline Flex W/Shield Technology	1	922	2.2%	84.5%
Px Slim Delivery Microcatheter	1	0	0.7%	95.7%
Ruby Coil Detachment Handle	1	0	0%	100%
Velocity Delivery Microcatheter	1	21	0%	91.4%

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
Penumbra	3,931	45.4%
Micro Therapeutics Ev3	1,495	17.3%
Concentric Medical	818	9.4%
Neuravi	796	9.2%
Covidien Irvine	363	4.2%
Stryker Neurovascular-Utah-Salt Lake City	208	2.4%
Medos International Sarl	113	1.3%
Stryker Neurovascular Cork	100	1.2%
Ev3 Neurovascular	81	0.9%
Microvention	57	0.7%
Covidien Medical Products	16	0.2%
Codman And Shurtleff	2	0%
Micrus Endovascular	2	0%

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

Death10.4%901

Injury40.1%3,474

Malfunction49.1%4,254

Other0.3%29

Not given0.1%5

Who filed

Manufacturer report97.9%8,483

Voluntary report1.1%95

User facility report0%0

Distributor report0.2%15

Not given0.8%70

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,422	16.4%
Physical resistance/sticking	932	10.8%
Fracturea broken bone	759	8.8%
Material deformation	560	6.5%
Kinkedthe tube or line kinked	441	5.1%
Insufficient device problem information	393	4.5%
Failure to advance	329	3.8%
Device damaged prior to usethe device was damaged before use	315	3.6%
Stretched	313	3.6%
Difficult to removethe device was hard to remove	286	3.3%
Out-of-box failure	252	2.9%
Material separation	219	2.5%
Physical resistance	215	2.5%
Device operates differently than expectedthe device behaved unexpectedly	179	2.1%
Retraction problem	170	2%
Difficult to advance	142	1.6%
Detachment of device component	117	1.4%
Material twisted/bent	105	1.2%
Suction problem	90	1%
Crackthe device cracked	78	0.9%

Questions about catheter, thrombus retriever reports

What is product code NRY?

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

How many reports carry this code?

8,663 reports through August 2026, 464 of them in the latest 12 months.

Which brands appear most often?

Solitaire Fr4 (590), Solitaire Fr (525), Penumbra System 3max Reperfusion Catheter (478), Penumbra System Jet7 Reperfusion Catheter (375) and Penumbra System 5max Ace Reperfusion Catheter (343). 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.