Azur CX Detachable 45-780928Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810170018343), received between Mar 9, 2023 and Mar 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Separation Failure” (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.
Most reported problems
Device problems
- Separation Failure1
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.
InjuryMar 9, 2023Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING EMBOLIZATION OF A PEDIATRIC VARICOCELE, TWO COILS WERE SUCCESSFULLY DEPLOYED AT THE TREATMENT SITE. ANOTHER COIL WAS GOING TO BE DEPLOYED TO COMPLETE THE COIL PACKING HOWEVER, THE COIL DID NOT DETACH WITH MULTIPLE ATTEMPTS INCLUDING TORQUING. THE COIL COULD NOT BE PULLED OUT USING VARIOUS BASE CATHETERS. CONVERTED TO LAPAROSCOPIC TO CUT VARICOCELE. THE COIL WAS ABLE TO BE PULLED FROM THE GROIN, BUT IT HAD STRETCHED OUT THE LENGTH OF THE VARICOCELE. THE COIL WAS REMOVED VIA SCOPE. FLURO EXAM WAS PERFORMED TO VERIFY NO PIECES HAD BROKEN OFF IN THE PATIENT. THE COIL PACK HAD PULLED BACK INTO RENAL VEIN/IVC. A SNARE WAS INTRODUCED TO REMOVE THE COIL PACK OUT OF THE PATIENT. THE PATIENT IS REPORTED TO BE STABLE. THE TREATMENT WAS ULTIMATELY SUCCESSFUL TAKING ANOTHER DIRECTION FOR TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519171 ↗
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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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