Devices › Agent, injectable, embolic
Device brand name · Agent injectable embolic
Onyx: medical device reports filed with FDA
1,357 reports name it, 2008–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code MFE.
- 1,357
- device reports naming the brand
- 0% of all MAUDE reports · about 74 a year
- 69
- reports, 12 months to August 2026
- 168 in the 12 months before
- 12%
- classified as malfunction
- 29.3% across the product code
- 13.4%
- classified as death, as reported
- 182 reports · not verified by FDA
FDA's MAUDE database holds 1,357 reports that name the brand "Onyx" (agent injectable embolic), received between March 2008 and August 2026; the manufacturer given most often on reports is Micro Therapeutics Ev3. Spellings of one product vary from report to report.
69 reports arrived in the 12 months to August 2026, down 59% from 168 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 (74.4%), death (13.4%) and malfunction (12%); across all agent, injectable, embolic reports (product code MFE) death is recorded in 8.6% and malfunction in 29.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (14.7%), entrapment of device (6.3%) and material rupture (2.3%). The patient problems coded most often are intracranial hemorrhage, hemorrhage/blood loss/bleeding and foreign body in patient. 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 3,106 reports carrying product code MFE. 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 |
|---|---|---|---|
| Migration or expulsion of device | 200 | 14.7% | 10.8% |
| Entrapment of device | 85 | 6.3% | 5.5% |
| Material rupture | 31 | 2.3% | 3.4% |
| Unintended movement | 28 | 2.1% | 1.5% |
| Insufficient device problem information | 21 | 1.5% | 2% |
| Fluid/blood leak | 10 | 0.7% | 0.8% |
| Chemical problem | 8 | 0.6% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 0.6% | 1.7% |
| Material separation | 8 | 0.6% | 0.7% |
| Breakthe device broke | 7 | 0.5% | 4.4% |
| Leak/splashthe device leaked | 6 | 0.4% | 3.9% |
| Premature activation | 6 | 0.4% | 1% |
| Difficult to removethe device was hard to remove | 5 | 0.4% | 2.6% |
| Hole in material | 5 | 0.4% | 0.2% |
| Malposition of device | 5 | 0.4% | 0.5% |
| Detachment of device component | 4 | 0.3% | 2.2% |
| Display or visual feedback problem | 4 | 0.3% | 1.7% |
| Failure to deliverthe device did not deliver the dose or item | 4 | 0.3% | 0.2% |
| Burst container or vessel | 3 | 0.2% | 4% |
| Improper or incorrect procedure or method | 3 | 0.2% | 0.2% |
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 | 189 | 13.9% |
| Hemorrhage/blood loss/bleeding | 119 | 8.8% |
| Foreign body in patientpart of a device left in the patient | 109 | 8% |
| Neurological deficit/dysfunction | 94 | 6.9% |
| Ischemia | 73 | 5.4% |
| Hematomaa collection of blood under the skin or in tissue | 71 | 5.2% |
| Paresis | 61 | 4.5% |
| Paralysis | 51 | 3.8% |
| Headachehead pain | 49 | 3.6% |
| Fistula | 48 | 3.5% |
| Nerve damage | 40 | 2.9% |
| Infarction, cerebral | 39 | 2.9% |
| Ischemia stroke | 38 | 2.8% |
| Stroke/cva | 38 | 2.8% |
| Therapeutic response, decreased | 37 | 2.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Onyx | Product code MFE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,357 | 3,106 | 26,136,888 |
| Share of that pool | — | 43.7% | 0% |
| Classified as death, per 1,000 reports | 134 | 86 | 9 |
| Classified as injury | 74.4% | 61.9% | 36.2% |
| Classified as malfunction | 12% | 29.3% | 62.3% |
| Filed by the manufacturer | 99.7% | 98.9% | 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 MFE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Onyx Avm | 854 | 27 | 4.9% |
| Apollo | 1,210 | 141 | 1.8% |
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 Onyx reports
How many FDA reports name Onyx?
1,357 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 69 in the latest 12 months.
What kinds of events are reported?
injury (74.4%), death (13.4%) and malfunction (12%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (14.7%), entrapment of device (6.3%), material rupture (2.3%), unintended movement (2.1%) and insufficient device problem information (1.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Onyx 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.