Azur Detachable Helical HydroCoil 45-481530Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170018060), received between Aug 23, 2021 and Feb 23, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
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.
MalfunctionFeb 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE MICROCATHETER WITH THE COIL WERE REMOVED AND WERE REPLACED WITH ANOTHER MICROCATHETER AND COIL. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR INTERVENTION. THE PATIENT IS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16433194 ↗MalfunctionAug 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A SPLENIC ARTERY ANEURYSM, AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY WITHIN THE MICROCATHETER. A SALINE FLUSH WAS USED TO PUSH THE COIL INTO THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12353442 ↗
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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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