Azur CX Detachable 45-750407Recalls & reported problems
Microvention, Inc. · Azur · Class 2 · Implant
All models of Azur CX Detachable (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812636021010), received between May 31, 2016 and May 7, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation2
- Detachment Of Device Component1
- Device Issue1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Aneurysm1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Premature Separation
IT WAS REPORTED THAT DURING AN INTERNAL ILIAC EMBOLIZATION CASE, THE COIL GOT STUCK WHEN THEY WERE PUSHING THE COIL THOUGH THE CATHETER. WHEN THEY PULLED THE COIL BACK OUT OF THE CATHETER IT DETACHED. THIS WAS THE FIRST COIL. ALL THE OTHER COILS WORKED CORRECTLY & THE CASE FINISHED SUCCESSFULLY. PATIENT LEFT THE ROOM IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113540 ↗MalfunctionSep 11, 2024Premature Separation; Premature Separation
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20192054 ↗MalfunctionJun 12, 2024
AZUR CX PERIPHERAL COIL SYSTEM DID NOT DEPLOY CORRECTLY IN VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519003 ↗MalfunctionFeb 6, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO RESHEATH AND REMOVE AN AZUR EMBOLIZATION COIL. DURING RETRACTION OF THE COIL, THE COIL DETACHED FROM THE PUSHER WIRE INSIDE THE CATHETER. THE PUSHER WIRE WAS PULLED OUT OF THE CATHETER, AND THE DETACHED COIL WAS THEN REMOVED ALONG WITH THE CATHETER AS IT WAS WITHDRAWN FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6303097 ↗InjuryMay 31, 2016Migration or Expulsion of Device; Device Issue; Migration or Expulsion of Device; Device Issue
IT WAS REPORTED THAT DURING A VESSEL EMBOLIZATION, THE COIL MIGRATED FROM THE INTENDED POSITION. THE COIL WAS SNARED INTO THE GUIDE CATHETER AND REMOVED SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: Aneurysm
MAUDE report 5689576 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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