Devices › Device, neurovascular embolization
Device brand name · Device neurovascular embolization
Axium: medical device reports filed with FDA
267 reports name it, 2015–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code HCG.
- 267
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 14
- reports, 12 months to August 2026
- 17 in the 12 months before
- 29.6%
- classified as malfunction
- 73% across the product code
- 13.1%
- classified as death, as reported
- 35 reports · not verified by FDA
FDA's MAUDE database holds 267 reports that name the brand "Axium" (device neurovascular embolization), received between August 2015 and August 2026; the manufacturer given most often on reports is Micro Therapeutics Ev3. Spellings of one product vary from report to report.
14 reports arrived in the 12 months to August 2026, down 18% from 17 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 injury (57.3%), malfunction (29.6%) and death (13.1%); across all device, neurovascular embolization reports (product code HCG) death is recorded in 2.4% and malfunction in 73%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are separation failure (17.6%), migration (5.2%) and insufficient device problem information (4.1%). The patient problems coded most often are intracranial hemorrhage, neurological deficit/dysfunction and inadequate pain relief. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,252 reports carrying product code HCG. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Separation failure | 47 | 17.6% | 3.8% |
| Migrationthe device moved from where it was placed | 14 | 5.2% | 1.3% |
| Insufficient device problem information | 11 | 4.1% | 1% |
| Physical resistance/sticking | 8 | 3% | 9.9% |
| Detachment of device or device componentpart of the device came off | 7 | 2.6% | 2.6% |
| Therapeutic or diagnostic output failure | 4 | 1.5% | 0% |
| Therapy delivered to incorrect body area | 4 | 1.5% | 0% |
| Unintended movement | 4 | 1.5% | 0.1% |
| Breakthe device broke | 3 | 1.1% | 5.7% |
| Difficult to removethe device was hard to remove | 2 | 0.7% | 2% |
| Stretched | 2 | 0.7% | 7.4% |
| Wireless communication problema wireless connection problem | 2 | 0.7% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.4% | 0% |
| Deformation due to compressive stress | 1 | 0.4% | 0.3% |
| Delivery system failure | 1 | 0.4% | 0.3% |
| Device dislodged or dislocated | 1 | 0.4% | 0.3% |
| Disconnection | 1 | 0.4% | 0.1% |
| Material deformation | 1 | 0.4% | 2.8% |
| No device output | 1 | 0.4% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.4% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Intracranial hemorrhage | 34 | 12.7% |
| Neurological deficit/dysfunction | 27 | 10.1% |
| Inadequate pain relief | 24 | 9% |
| Hemorrhage/blood loss/bleeding | 19 | 7.1% |
| Thrombosis | 16 | 6% |
| Aneurysm | 12 | 4.5% |
| Thrombosis/thrombus | 12 | 4.5% |
| Stenosis | 10 | 3.7% |
| Deaththe patient died; cause not stated by this term | 9 | 3.4% |
| Hematomaa collection of blood under the skin or in tissue | 9 | 3.4% |
| Hydrocephalus | 9 | 3.4% |
| Ischemia stroke | 9 | 3.4% |
| Muscle weakness/atrophy | 9 | 3.4% |
| Obstruction/occlusion | 9 | 3.4% |
| Ischemia | 8 | 3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Axium | Product code HCG | All MAUDE reports |
|---|---|---|---|
| Reports | 267 | 26,252 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 131 | 24 | 9 |
| Classified as injury | 57.3% | 24% | 36.2% |
| Classified as malfunction | 29.6% | 73% | 62.3% |
| Filed by the manufacturer | 99.3% | 98.5% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code HCG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ruby Coil | 3,360 | 26 | 0.1% |
| Penumbra Smart Coil | 2,781 | 3 | 0.3% |
| Penumbra Coil 400 | 1,453 | 0 | 0.9% |
| POD Packing Coil | 1,062 | 35 | 0% |
| Trufill Dcs Orbit Mini Complex Fill | 735 | 0 | 1.6% |
| Ruby Coil Lp | 479 | 13 | 0% |
| Pod | 406 | 18 | 0% |
| Trufill Dcs Orbit Detachable Coils Complex | 395 | 0 | 0.8% |
| Deltaplush - Cerecyte Microcoil | 392 | 0 | 0.3% |
| Penumbra Smart Coil Detachment Handle | 317 | 0 | 0% |
| Deltapaq - Cerecyte Microcoil | 295 | 0 | 0% |
| Orbit Galaxy Detachable Coil System | 273 | 0 | 0.4% |
| Optima Coil System | 255 | 55 | 2% |
| Packing Coil LP | 235 | 11 | 0% |
| Xtrasoft Orbit Galaxy Detachable Coil | 235 | 0 | 1.3% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Axium reports
How many FDA reports name Axium?
267 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 14 in the latest 12 months.
What kinds of events are reported?
injury (57.3%), malfunction (29.6%) and death (13.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
separation failure (17.6%), migration (5.2%), insufficient device problem information (4.1%), physical resistance/sticking (3%) and detachment of device or device component (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Axium was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.