Device, vascular, for promoting embolization: medical device reports filed with FDA

14,553 reports carry this product code, 1992–2026; 30 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.

14,553
reports with this product code: 0.1% of all MAUDE reports; 1,671
reports, 12 months to August 2026: 1,580 in the 12 months before; 74.9%
classified as malfunction: 62.3% across all reports; 1.6%
classified as death, as reported: 0.9% across all reports

Product code KRD is FDA's classification for "Device, vascular, for promoting embolization" (cardiovascular panel), a class 2 device. 14,553 medical device reports carry this product code, 0.1% of the MAUDE database, from June 1992 to August 2026.

1,671 reports arrived in the 12 months to August 2026, close to the 1,580 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 (74.9%), injury (22.9%) and death (1.6%). 30 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
Axium Prime Brpl 3d	902	135	1%	91.5%
Concerto Nylon	900	160	2.6%	91.9%
Interlock?	688	37	0%	81.3%
Interlock-35	626	2	0.2%	92.3%
Axium Prime Brpl Hlx	616	106	1%	90.6%
Interlock?-35	542	94	2.2%	79.7%
Axium 3d	429	48	1.6%	90%
AZUR CX 35 Detachable	385	58	0%	76%
Axium Framing Coil	282	57	0%	93%
Azur CX Detachable	278	38	0%	78.8%
Concerto Pgla Hlx	247	54	0.8%	91.5%
Axium Helix	231	24	3%	81%
Retracta Detachable Embolization Coil	228	20	0.9%	78.9%
Microvascular Plug	164	11	0.6%	53.9%
Axium Prime Bare Pl 3d	150	27	0%	92%
Concerto	78	199	2.7%	62.8%
Axium	74	14	13.1%	29.6%
Uterine Artery Embolization	70	0	1.1%	0%
Dc Bead	40	1	26.5%	0.7%
Penumbra Coil 400	15	0	0.9%	78%
Ruby Coil	12	26	0.1%	95.2%
Xtrasoft Orbit Galaxy Detachable Coil	5	0	1.3%	66%
Orbit Galaxy Detachable Coil System	4	0	0.4%	72.9%
Rx Accunet Embolic Protection System	3	0	2.1%	14%
Boston Scientific	1	5	3.3%	55%
Cathera	1	0	7.3%	66.1%
Deltaplush - Cerecyte Microcoil	1	0	0.3%	90.8%
Rebar	1	108	9%	62.8%
Terumo	1	0	2.8%	12.2%
Therasphere	1	0	34.8%	0.5%

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	2,655	18.2%
Micro Therapeutics Ev3	2,398	16.5%
Microvention	1,803	12.4%
Medtronic Mexico S De R L De Cv	887	6.1%
Boston Scientific - Cork	860	5.9%
Covidien Irvine	687	4.7%
Medtronic Mexico	406	2.8%
Cook	368	2.5%
Aga Medical	210	1.4%
Penumbra	145	1%
Codman And Shurtleff	73	0.5%
William Cook Europe	49	0.3%
Abbott Medical	47	0.3%
Covidien Medical Products	20	0.1%
Clearstream Technologies	16	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

Death1.6%240

Injury22.9%3,329

Malfunction74.9%10,902

Other0.5%74

Not given0.1%8

Who filed

Manufacturer report97.3%14,162

Voluntary report1.3%184

User facility report0%0

Distributor report0%5

Not given1.4%202

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

Device problems coded

Device problem (FDA code)	Reports	Share
Separation failure	2,729	18.8%
Detachment of device or device componentpart of the device came off	1,830	12.6%
Stretched	1,612	11.1%
Physical resistance/sticking	1,356	9.3%
Failure to advance	985	6.8%
Premature separation	972	6.7%
Breakthe device broke	913	6.3%
Detachment of device component	559	3.8%
Material deformation	511	3.5%
Entrapment of device	498	3.4%
Migrationthe device moved from where it was placed	488	3.4%
Difficult to advance	479	3.3%
Premature activation	449	3.1%
Difficult to removethe device was hard to remove	441	3%
Migration or expulsion of device	437	3%
Unraveled material	286	2%
Positioning problem	254	1.7%
Material twisted/bent	239	1.6%
Material protrusion/extrusion	218	1.5%
Material separation	198	1.4%

Questions about device, vascular, for promoting embolization reports

What is product code KRD?

FDA's classification code for "Device, vascular, for promoting embolization", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

14,553 reports through August 2026, 1,671 of them in the latest 12 months.

Which brands appear most often?

Axium Prime Brpl 3d (902), Concerto Nylon (900), Interlock? (688), Interlock-35 (626) and Axium Prime Brpl Hlx (616). 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.