Device, neurovascular embolization: medical device reports filed with FDA

26,252 reports carry this product code, 1995–2026; 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.

26,252
reports with this product code: 0.1% of all MAUDE reports; 561
reports, 12 months to August 2026: 505 in the 12 months before; 73%
classified as malfunction: 62.3% across all reports; 2.4%
classified as death, as reported: 0.9% across all reports

Product code HCG is FDA's classification for "Device, neurovascular embolization" (neurology panel), a class 2 device. 26,252 medical device reports carry this product code, 0.1% of the MAUDE database, from June 1995 to August 2026.

561 reports arrived in the 12 months to August 2026, up 11% from 505 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 (73%), injury (24%) and death (2.4%). 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
Ruby Coil	3,347	26	0.1%	95.2%
Penumbra Smart Coil	2,781	3	0.3%	92.3%
Penumbra Coil 400	1,438	0	0.9%	78%
POD Packing Coil	1,062	35	0%	93%
Trufill Dcs Orbit Mini Complex Fill	735	0	1.6%	72.8%
Ruby Coil Lp	479	13	0%	99.2%
Pod	405	18	0%	98.5%
Trufill Dcs Orbit Detachable Coils Complex	395	0	0.8%	67.3%
Deltaplush - Cerecyte Microcoil	391	0	0.3%	90.8%
Penumbra Smart Coil Detachment Handle	317	0	0%	100%
Deltapaq - Cerecyte Microcoil	295	0	0%	75.3%
Orbit Galaxy Detachable Coil System	269	0	0.4%	72.9%
Optima Coil System	255	55	2%	86.3%
Packing Coil LP	235	11	0%	100%
Xtrasoft Orbit Galaxy Detachable Coil	230	0	1.3%	66%
Axium 3-D Detachable Coil	222	0	0.5%	58.1%
Presidio 10 - Cerecyte Microcoil	193	0	1%	79.3%
Pipeline Embolization Device	187	0	10.3%	25.6%
Ruby Coil Detachment Handle	174	0	0%	100%
Unknown_Neurovascular_Product	171	48	12.9%	15.3%
Presidio 18 - Cerecyte Microcoil	168	0	0%	85.1%
Axium Helix Detachable Coil	156	0	0.6%	56.4%
Axium	152	14	13.1%	29.6%
Dc Bead	110	1	26.5%	0.7%
Micrus Microcoil System	80	0	5.4%	46.1%
Uterine Artery Embolization	9	0	1.1%	0%
Lantern Delivery Microcatheter	5	19	0%	98.5%
Axium Framing Coil	4	57	0%	93%
AZUR CX 35 Detachable	3	58	0%	76%
Penumbra System Jet7 Reperfusion Catheter	3	0	4%	81.5%

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
Penumbra	11,243	42.8%
Stryker Neurovascular Cork	2,772	10.6%
Microvention	2,011	7.7%
Cordis Neurovascular	1,638	6.2%
Micrus Endovascular	1,364	5.2%
Ev3 Neurovascular	1,186	4.5%
Codman And Shurtleff	962	3.7%
Medos International Sarl	789	3%
Boston Scientific - Cork	705	2.7%
Micro Therapeutics Ev3	157	0.6%
Stryker	20	0.1%
Cordis	19	0.1%
Covidien Irvine	18	0.1%
Ev3	10	0%
Codman & Shurtleff	5	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

Death2.4%640

Injury24%6,292

Malfunction73%19,170

Other0.2%53

Not given0.4%97

Who filed

Manufacturer report98.5%25,871

Voluntary report0.7%181

User facility report0%0

Distributor report0%11

Not given0.7%189

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to advance	4,259	16.2%
Physical resistance/sticking	2,612	9.9%
Premature separation	2,484	9.5%
Detachment of device component	2,119	8.1%
Physical resistance	2,080	7.9%
Stretched	1,939	7.4%
Breakthe device broke	1,507	5.7%
Premature activation	1,479	5.6%
Positioning failure	1,223	4.7%
Separation failure	985	3.8%
Kinkedthe tube or line kinked	742	2.8%
Material deformation	737	2.8%
Other (for use when an appropriate device code cannot be identified)	699	2.7%
Detachment of device or device componentpart of the device came off	677	2.6%
Migration or expulsion of device	610	2.3%
Fracturea broken bone	598	2.3%
Difficult to removethe device was hard to remove	532	2%
Unraveled material	531	2%
Mechanical problema mechanical problem	530	2%
Device operates differently than expectedthe device behaved unexpectedly	466	1.8%

Questions about device, neurovascular embolization reports

What is product code HCG?

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

How many reports carry this code?

26,252 reports through August 2026, 561 of them in the latest 12 months.

Which brands appear most often?

Ruby Coil (3,347), Penumbra Smart Coil (2,781), Penumbra Coil 400 (1,438), POD Packing Coil (1,062) and Trufill Dcs Orbit Mini Complex Fill (735). 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.