Devices › Device, neurovascular embolization
Device brand name · Detachable coil
Axium Helix Detachable Coil: medical device reports filed with FDA
156 reports name it, 2007–2012. Manufacturer given most often on reports: Ev3 Neurovascular. Product code HCG.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 56.4%
- classified as malfunction
- 73% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
156 medical device reports received by FDA name the brand "Axium Helix Detachable Coil" (detachable coil); the manufacturer given most often on reports is Ev3 Neurovascular; received from September 2007 to October 2012. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (56.4%), injury (42.9%) and death (0.6%); 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 premature activation (30.8%), detachment of device component (26.9%) and positioning failure (15.4%). The patient problems coded most often are foreign body, removal of, hospitalization required and no patient involvement. 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
No report naming Axium Helix Detachable Coil was received in the five years to August 2026; the latest was received in October 2012.
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 |
|---|---|---|---|
| Premature activation | 48 | 30.8% | 5.6% |
| Detachment of device component | 42 | 26.9% | 8.1% |
| Positioning failure | 24 | 15.4% | 4.7% |
| Malposition of device | 15 | 9.6% | 0.6% |
| Difficult to removethe device was hard to remove | 10 | 6.4% | 2% |
| Separation failure | 10 | 6.4% | 3.8% |
| Device, removal of (non-implant) | 9 | 5.8% | 0.9% |
| Migration or expulsion of device | 9 | 5.8% | 2.3% |
| Breakthe device broke | 6 | 3.8% | 5.7% |
| Failure to disconnect | 6 | 3.8% | 0.3% |
| Device dislodged or dislocated | 5 | 3.2% | 0.3% |
| Physical resistance | 4 | 2.6% | 7.9% |
| Device remains implanted | 3 | 1.9% | 1.4% |
| Difficult to insertthe device was hard to insert | 3 | 1.9% | 0.8% |
| Insufficient device problem information | 3 | 1.9% | 1% |
| Component missing | 2 | 1.3% | 0.1% |
| Device, or device fragments remain in patient | 2 | 1.3% | 0.7% |
| Difficult or delayed positioning | 2 | 1.3% | 0.9% |
| Difficult to position | 2 | 1.3% | 1% |
| Failure to advance | 2 | 1.3% | 16.2% |
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 |
|---|---|---|
| Foreign body, removal of | 6 | 3.8% |
| Hospitalization required | 3 | 1.9% |
| No patient involvement | 3 | 1.9% |
| Nonresorbable materials, unretrieved in body | 3 | 1.9% |
| Perforation | 3 | 1.9% |
| Rupturethe device burst | 3 | 1.9% |
| Stroke | 3 | 1.9% |
| Bleeding | 2 | 1.3% |
| Device embedded in tissue or plaque | 2 | 1.3% |
| Hemorrhage/blood loss/bleeding | 2 | 1.3% |
| Myocardial infarctionheart attack | 2 | 1.3% |
| Therapy/non-surgical treatment, additional | 2 | 1.3% |
| Thrombus | 2 | 1.3% |
| Deaththe patient died; cause not stated by this term | 1 | 0.6% |
| Dural tear | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Axium Helix Detachable Coil | Product code HCG | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 26,252 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 24 | 9 |
| Classified as injury | 42.9% | 24% | 36.2% |
| Classified as malfunction | 56.4% | 73% | 62.3% |
| Filed by the manufacturer | 100% | 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 Helix Detachable Coil reports
How many FDA reports name Axium Helix Detachable Coil?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (56.4%), injury (42.9%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature activation (30.8%), detachment of device component (26.9%), positioning failure (15.4%), malposition of device (9.6%) and difficult to remove (6.4%). 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 Detachable Coil 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.