Catheter, embolectomy: medical device reports filed with FDA

7,789 reports carry this product code, 1992–2026; 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.

7,789
reports with this product code: 0% of all MAUDE reports; 468
reports, 12 months to August 2026: 307 in the 12 months before; 80.1%
classified as malfunction: 62.3% across all reports; 1.8%
classified as death, as reported: 0.9% across all reports

Product code DXE is FDA's classification for "Catheter, embolectomy" (cardiovascular panel), a class 2 device. 7,789 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

468 reports arrived in the 12 months to August 2026, up 52% from 307 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 (80.1%), injury (14.4%) and other (3.2%). 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
Fogarty Arterial Embolectomy Catheter	1,155	37	0.2%	87.4%
AngioJet SOLENT omni	609	26	1.3%	93.1%
Fogarty Thru-Lumen Embolectomy Catheter	426	76	0.7%	95.8%
Indigo System Aspiration Catheter 6	396	0	0%	97.2%
TufTex Over-the-Wire Embolectomy Catheter	360	159	0%	99.7%
Angiojet Zelantedvt	248	0	5.3%	76.3%
Indigo System Aspiration Catheter 8	169	2	1.5%	90.8%
Indigo System Separator 8	122	4	1.9%	75.8%
Indigo System Catrx Aspiration Catheter	96	11	0%	90.7%
AngioJet SOLENT Proxi	33	5	4.6%	84.6%
AdvanCE	31	8	2.7%	72.7%
Pruitt F3 Carotid Shunt	23	73	0.3%	92.9%
Internal Hex Implant	2	0	0%	0%
Galileo	1	0	0.1%	97.6%
Penumbra System Jet7 Reperfusion Catheter	1	0	4%	81.5%
Ruby Coil	1	26	0.1%	95.2%

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
Edwards Lifesciences Pr	1,597	20.5%
Penumbra	1,303	16.7%
Boston Scientific - Maple Grove	929	11.9%
Lemaitre Vascular	826	10.6%
Arrow International	376	4.8%
Edwards Lifesciences	307	3.9%
Applied Medical Resources	199	2.6%
Arrow Intl	175	2.2%
Medos International Sarl	116	1.5%
Vascular Solutions	87	1.1%
Applied Medical	55	0.7%
Boston Scientific	53	0.7%
Medtronic	44	0.6%
Ev3	32	0.4%
Merit Medical Systems	15	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

Death1.8%143

Injury14.4%1,118

Malfunction80.1%6,240

Other3.2%250

Not given0.5%38

Who filed

Manufacturer report93%7,247

Voluntary report2.8%217

User facility report0%0

Distributor report0.1%5

Not given4.1%320

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	988	12.7%
Material rupture	918	11.8%
Aspiration issue	501	6.4%
Material deformation	471	6%
Device displays incorrect message	454	5.8%
Material separation	447	5.7%
Material fragmentation	441	5.7%
Detachment of device component	385	4.9%
Deflation problem	307	3.9%
Detachment of device or device componentpart of the device came off	298	3.8%
Kinkedthe tube or line kinked	245	3.1%
Physical resistance/sticking	218	2.8%
Difficult to removethe device was hard to remove	202	2.6%
Leak/splashthe device leaked	199	2.6%
Device damaged prior to usethe device was damaged before use	178	2.3%
Suction problem	163	2.1%
Burst container or vessel	161	2.1%
Tip breakage	155	2%
Failure to advance	143	1.8%
Physical resistance	143	1.8%

Questions about catheter, embolectomy reports

What is product code DXE?

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

How many reports carry this code?

7,789 reports through August 2026, 468 of them in the latest 12 months.

Which brands appear most often?

Fogarty Arterial Embolectomy Catheter (1,155), AngioJet SOLENT omni (609), Fogarty Thru-Lumen Embolectomy Catheter (426), Indigo System Aspiration Catheter 6 (396) and TufTex Over-the-Wire Embolectomy Catheter (360). 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.