Azur CX Detachable 45-781836Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810170018398), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).
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
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Difficult or Delayed Separation
AS REPORTED: A PATIENT WHO, PRIOR TO ABDOMINAL STENT GRAFT IMPLANTATION, UNDERGOES COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. THE VESSEL HAD NO LESIONS; IT SIMPLY NEEDED TO BE OCCLUDED PRIOR TO STENT IMPLANTATION. A PUNCTURE IS MADE IN THE RIGHT FEMORAL ARTERY USING A 5F INTRODUCER; A COBRA 2 CATHETER IS ADVANCED TO CATHETERIZE THE ARTERY, AND A SECOND COIL OF THE SAME SIZE IS THEN PLACED. NEXT, AN 18 MM × 36 CM AZUR CX18 COIL IS PLACED, WHICH DOES NOT RELEASE EASILY BUT EVENTUALLY DETACHES ON ITS OWN, REMAINS IMPLANTED. ANOTHER COIL OF THE SAME SIZE IS PLACED WHICH, AFTER MULTIPLE ATTEMPTS AND A CHANGE OF RELEASE MECHANISM, CANNOT BE IMPLANTED; THEREFORE, IT HAS BEEN DECIDED TO WITHDRAW IT . THERE WAS NO PATIENT IMPACT OR INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL CLARIFICATION HAS BEEN RECEIVED. THIS REPORT CAPTURES THE ISSUE WITH THE COIL THAT "DETACHED ON ITS OWN" AND REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24804339 ↗
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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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