Devices › Agent, injectable, embolic
Device brand name · Agent injectable embolic
Apollo: medical device reports filed with FDA
1,210 reports name it, 2005–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code MFE.
- 1,210
- device reports naming the brand
- 0% of all MAUDE reports · about 56 a year
- 141
- reports, 12 months to August 2026
- 135 in the 12 months before
- 84.1%
- classified as malfunction
- 29.3% across the product code
- 1.8%
- classified as death, as reported
- 22 reports · not verified by FDA
1,210 medical device reports received by FDA name the brand "Apollo" (agent injectable embolic); the manufacturer given most often on reports is Micro Therapeutics Ev3; received from January 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
141 reports arrived in the 12 months to August 2026, close to the 135 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 (84.1%), injury (12.5%) and death (1.8%); 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 failure to deliver (22.6%), gas output problem (17.1%) and detachment of device or device component (15.9%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and intracranial hemorrhage. 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 |
|---|---|---|---|
| Failure to deliverthe device did not deliver the dose or item | 274 | 22.6% | 0.2% |
| Gas output problem | 207 | 17.1% | 0% |
| Detachment of device or device componentpart of the device came off | 192 | 15.9% | 6.5% |
| Burst container or vessel | 112 | 9.3% | 4% |
| Leak/splashthe device leaked | 88 | 7.3% | 3.9% |
| Breakthe device broke | 80 | 6.6% | 4.4% |
| Physical resistance/sticking | 80 | 6.6% | 2.8% |
| Intermittent continuity | 79 | 6.5% | 0% |
| Device displays incorrect message | 77 | 6.4% | 0% |
| Device inoperablethe device could not be used | 60 | 5% | 0% |
| Difficult to removethe device was hard to remove | 44 | 3.6% | 2.6% |
| Intermittent communication failure | 41 | 3.4% | 0% |
| Compatibility problem | 38 | 3.1% | 1.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 35 | 2.9% | 1.7% |
| Detachment of device component | 34 | 2.8% | 2.2% |
| No pressure | 33 | 2.7% | 0% |
| Material deformation | 30 | 2.5% | 1% |
| Pressure problem | 26 | 2.1% | 0% |
| Packaging problem | 25 | 2.1% | 0.9% |
| Protective measures problem | 23 | 1.9% | 0% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 123 | 10.2% |
| Device embedded in tissue or plaque | 29 | 2.4% |
| Intracranial hemorrhage | 22 | 1.8% |
| Hemorrhage/blood loss/bleeding | 15 | 1.2% |
| Vasoconstriction | 14 | 1.2% |
| Obstruction/occlusion | 12 | 1% |
| Hematomaa collection of blood under the skin or in tissue | 9 | 0.7% |
| Deaththe patient died; cause not stated by this term | 8 | 0.7% |
| Rupturethe device burst | 8 | 0.7% |
| Headachehead pain | 7 | 0.6% |
| Ischemia stroke | 7 | 0.6% |
| Perforation of vessels | 7 | 0.6% |
| Ischemia | 6 | 0.5% |
| Muscle weakness/atrophy | 6 | 0.5% |
| Stroke/cva | 6 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Apollo | Product code MFE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,210 | 3,106 | 26,136,888 |
| Share of that pool | — | 39% | 0% |
| Classified as death, per 1,000 reports | 18 | 86 | 9 |
| Classified as injury | 12.5% | 61.9% | 36.2% |
| Classified as malfunction | 84.1% | 29.3% | 62.3% |
| Filed by the manufacturer | 96.2% | 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 | 1,357 | 69 | 13.4% |
| Onyx Avm | 854 | 27 | 4.9% |
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 Apollo reports
How many FDA reports name Apollo?
1,210 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 141 in the latest 12 months.
What kinds of events are reported?
malfunction (84.1%), injury (12.5%) and death (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to deliver (22.6%), gas output problem (17.1%), detachment of device or device component (15.9%), burst container or vessel (9.3%) and leak/splash (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.2%), voluntary reports (0.5%) and distributor reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Apollo 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.