Devices › Device, vascular, for promoting embolization
Device brand name · Device vascular for promoting embolization
Axium Helix: medical device reports filed with FDA
231 reports name it, 2015–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code KRD.
- 231
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 24
- reports, 12 months to August 2026
- 37 in the 12 months before
- 81%
- classified as malfunction
- 74.9% across the product code
- 3%
- classified as death, as reported
- 7 reports · not verified by FDA
231 medical device reports received by FDA name the brand "Axium Helix" (device vascular for promoting embolization); the manufacturer given most often on reports is Micro Therapeutics Ev3; received from November 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
24 reports arrived in the 12 months to August 2026, down 35% from 37 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 (81%), injury (16%) and death (3%); across all device, vascular, for promoting embolization reports (product code KRD) death is recorded in 1.6% and malfunction in 74.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are physical resistance/sticking (24.2%), separation failure (21.6%) and detachment of device or device component (20.3%). The patient problems coded most often are aneurysm, foreign body in patient and device embedded in tissue or plaque. 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 14,553 reports carrying product code KRD. 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 |
|---|---|---|---|
| Physical resistance/sticking | 56 | 24.2% | 9.3% |
| Separation failure | 50 | 21.6% | 18.8% |
| Detachment of device or device componentpart of the device came off | 47 | 20.3% | 12.6% |
| Stretched | 32 | 13.9% | 11.1% |
| Breakthe device broke | 24 | 10.4% | 6.3% |
| Material deformation | 20 | 8.7% | 3.5% |
| Packaging problem | 9 | 3.9% | 0.9% |
| Detachment of device component | 7 | 3% | 3.8% |
| Unintended movement | 6 | 2.6% | 1.2% |
| Inadequacy of device shape and/or size | 5 | 2.2% | 0.6% |
| Therapy delivered to incorrect body area | 5 | 2.2% | 0.4% |
| Migrationthe device moved from where it was placed | 4 | 1.7% | 3.4% |
| Difficult or delayed positioning | 3 | 1.3% | 0.8% |
| Contamination | 1 | 0.4% | 0.1% |
| Difficult to position | 1 | 0.4% | 0.4% |
| Display or visual feedback problem | 1 | 0.4% | 0.1% |
| Insufficient device problem information | 1 | 0.4% | 0.4% |
| Retraction problem | 1 | 0.4% | 0.3% |
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 |
|---|---|---|
| Aneurysm | 19 | 8.2% |
| Foreign body in patientpart of a device left in the patient | 14 | 6.1% |
| Device embedded in tissue or plaque | 2 | 0.9% |
| Intracranial hemorrhage | 2 | 0.9% |
| Numbnessnumbness | 2 | 0.9% |
| Obstruction/occlusion | 2 | 0.9% |
| Paresis | 2 | 0.9% |
| Stenosis | 2 | 0.9% |
| Headachehead pain | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
| Hemorrhagic stroke | 1 | 0.4% |
| Therapeutic response, decreased | 1 | 0.4% |
| Thrombosis/thrombus | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Axium Helix | Product code KRD | All MAUDE reports |
|---|---|---|---|
| Reports | 231 | 14,553 | 26,136,888 |
| Share of that pool | — | 1.6% | 0% |
| Classified as death, per 1,000 reports | 30 | 16 | 9 |
| Classified as injury | 16% | 22.9% | 36.2% |
| Classified as malfunction | 81% | 74.9% | 62.3% |
| Filed by the manufacturer | 100% | 97.3% | 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 KRD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Axium Prime Brpl 3d | 902 | 135 | 1% |
| Concerto Nylon | 900 | 160 | 2.6% |
| Interlock? | 688 | 37 | 0% |
| Interlock-35 | 626 | 2 | 0.2% |
| Axium Prime Brpl Hlx | 616 | 106 | 1% |
| Interlock?-35 | 542 | 94 | 2.2% |
| Axium 3d | 429 | 48 | 1.6% |
| AZUR CX 35 Detachable | 388 | 58 | 0% |
| Axium Framing Coil | 286 | 57 | 0% |
| Azur CX Detachable | 278 | 38 | 0% |
| Concerto Pgla Hlx | 247 | 54 | 0.8% |
| Retracta Detachable Embolization Coil | 228 | 20 | 0.9% |
| Microvascular Plug | 165 | 11 | 0.6% |
| Axium Prime Bare Pl 3d | 150 | 27 | 0% |
| Concerto | 843 | 199 | 2.7% |
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 Helix reports
How many FDA reports name Axium Helix?
231 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.
What kinds of events are reported?
malfunction (81%), injury (16%) and death (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
physical resistance/sticking (24.2%), separation failure (21.6%), detachment of device or device component (20.3%), stretched (13.9%) and break (10.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Axium Helix 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.