Azur Detachable Helical HydroCoil 45-450610Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170014918), received between Apr 7, 2016 and Jun 2, 2023 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Device Issue1
- Stretched1
Patient problems
- Aneurysm1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2023Component Missing; Component Missing
IT WAS REPORTED THAT UPON OPENING THE COIL PACKAGE THERE WAS NO COIL IN THE PACKAGE. THE HOOP WAS IN THE PACKAGE BUT THERE WAS NO COIL IN IT. THE CASE WAS AN EMBOLIZATION OF GASTRIC VARICES, AND IT WAS COMPLETED SUCCESSFULLY WITH ANOTHER COIL. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056310 ↗DeathApr 7, 2016Stretched; Device Issue; Stretched; Device Issue
IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, UPON COIL POSITIONING AND PACKING, THE COIL WAS REPORTED TO STRETCH. IT WAS REPORTED THAT THE PATIENT DIED DUE TO TRAUMA. IT WAS STATED THAT IT WAS NOT DEVICE RELATED. ADDITIONAL INFORMATION RECEIVED ON MARCH 16, 2016: THE STRETCHED COIL AND DELIVERY PUSHER WERE REMOVED TOGETHER WITH THE MICROCATHETER WITHOUT INCIDENT.
Patient problems: Aneurysm
MAUDE report 5556130 ↗
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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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