Devices › Device, vascular, for promoting embolization
Device brand name · Vascular embolization device
AZUR CX 35 Detachable: medical device reports filed with FDA
388 reports name it, 2017–2026. Manufacturer given most often on reports: Microvention. Product code KRD.
- 388
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 58
- reports, 12 months to August 2026
- 38 in the 12 months before
- 76%
- classified as malfunction
- 74.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
388 medical device reports received by FDA name the brand "AZUR CX 35 Detachable" (vascular embolization device); the manufacturer given most often on reports is Microvention; received from March 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
58 reports arrived in the 12 months to August 2026, up 53% from 38 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 (76%) and injury (24%); 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 premature separation (44.8%), detachment of device or device component (35.1%) and stretched (10.8%). The patient problems coded most often are hematoma, hemorrhage/blood loss/bleeding 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
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 |
|---|---|---|---|
| Premature separation | 174 | 44.8% | 6.7% |
| Detachment of device or device componentpart of the device came off | 136 | 35.1% | 12.6% |
| Stretched | 42 | 10.8% | 11.1% |
| Detachment of device component | 35 | 9% | 3.8% |
| Unraveled material | 27 | 7% | 2% |
| Device-device incompatibility | 18 | 4.6% | 1% |
| Difficult to removethe device was hard to remove | 10 | 2.6% | 3% |
| Separation failure | 10 | 2.6% | 18.8% |
| Difficult or delayed separation | 6 | 1.5% | 0.9% |
| Component missing | 5 | 1.3% | 0.2% |
| Difficult to position | 5 | 1.3% | 0.4% |
| Migrationthe device moved from where it was placed | 5 | 1.3% | 3.4% |
| Difficult to advance | 4 | 1% | 3.3% |
| Material separation | 4 | 1% | 1.4% |
| Fracturea broken bone | 3 | 0.8% | 0.6% |
| Difficult or delayed positioning | 2 | 0.5% | 0.8% |
| Improper or incorrect procedure or method | 2 | 0.5% | 0.2% |
| Malposition of device | 2 | 0.5% | 1% |
| Separation problem | 2 | 0.5% | 0.3% |
| Migration or expulsion of device | 1 | 0.3% | 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 |
|---|---|---|
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| No patient involvement | 1 | 0.3% |
| Pulmonary embolisma blood clot in the lung | 1 | 0.3% |
| Rashskin rash | 1 | 0.3% |
| Vascular dissection | 1 | 0.3% |
| Vasoconstriction | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AZUR CX 35 Detachable | Product code KRD | All MAUDE reports |
|---|---|---|---|
| Reports | 388 | 14,553 | 26,136,888 |
| Share of that pool | — | 2.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 16 | 9 |
| Classified as injury | 24% | 22.9% | 36.2% |
| Classified as malfunction | 76% | 74.9% | 62.3% |
| Filed by the manufacturer | 99.7% | 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% |
| Axium Framing Coil | 286 | 57 | 0% |
| Azur CX Detachable | 278 | 38 | 0% |
| Concerto Pgla Hlx | 247 | 54 | 0.8% |
| Axium Helix | 231 | 24 | 3% |
| 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 AZUR CX 35 Detachable reports
How many FDA reports name AZUR CX 35 Detachable?
388 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 58 in the latest 12 months.
What kinds of events are reported?
malfunction (76%) and injury (24%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature separation (44.8%), detachment of device or device component (35.1%), stretched (10.8%), detachment of device component (9%) and unraveled material (7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that AZUR CX 35 Detachable 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.