Azur Detachable Helical HydroCoil 45-480510Recalls & reported problems
Microvention, Inc. · Azur · Class 2 · Implant
All models of Azur Detachable Helical HydroCoil (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812636020488), received between May 26, 2023 and Jun 10, 2025 — classified as 1 injury, 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
- Difficult to Remove1
- Entrapment of Device1
- Premature Separation1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2025Entrapment of Device; Difficult to Remove; Unraveled Material; Difficult or Delayed Separation; Entrapment of Device; Difficult to Remove; Unraveled Material; Difficult or Delayed Separation
IT WAS REPORTED THAT DURING A RENAL EMBOLIZATION PROCEDURE, THE COIL UNSUCCESSFULLY DEPLOYED AFTER MULTIPLE (NORMAL) CYCLES WITH CONTROLLER. PHYSICIAN TRIED TO MANUALLY DEPLOY VIA PUSHER WIRE ROTATION. COIL DEPLOYED BUT SUPPORT MICROCATHETER WAS A DISTANCE AWAY FROM THE END OF COIL. UPON DEPLOYMENT RECOIL OF THE ADHESIVE STRIP (CONDUIT FOR THE THERMO / ELECTRIC DISCHARGE THAT IS AFFIXED ON THE WIRE) WRAPPED THE COIL. ADHESIVE STRIP FINALLY DISENGAGED WITH A SMALL TAG END LEFT THAT WAS STILL IN THE TARGET ARTERY. THE PUSHER WIRE WAS DETACHED BUT ROTATION AND WAS REMOVED W/O INCIDENT. NO INTERVENTION WAS USED TO REMOVE THE COIL. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22181540 ↗MalfunctionMay 26, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING COIL EMBOLIZATION TREATMENT, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE ENTIRE COIL AND CATHETER WERE REMOVED FROM THE PATIENT. ANOTHER COIL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY OR INTERVENTION. THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17013406 ↗
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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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