Azur Detachable Helical HydroCoil 45-481020Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810170018015), received between Aug 18, 2016 and Aug 15, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment Of 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.
Reports received per month
Most reported problems
Device problems
- Detachment Of Device Component2
- Device Issue2
- Premature Separation1
Patient problems
- Aneurysm2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Premature Separation; Premature Separation
PLEASE SEE SECTION H11 FOR CORRECTION TO INCLUDE SERIOUS INJURY, AS THE COIL DETACHED WITHOUT USING THE DETACHMENT CONTROLLER BEFORE REACHING THE TARGET SITE AND THEREFORE, EMBOLIZATION OF AN ARTERY OTHER THAN THE ONE INITIALLY INTENDED OCCURRED AS THE COIL WAS LEFT IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22814999 ↗InjuryAug 18, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM, THE COIL BROKE OR PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE COIL WAS PUSHED OUT TO THE INTENDED SITE USING A SYRINGE. THIS IS 1 OF 2 DEVICES REPORTED DURING THIS INCIDENT. THE OTHER IS REPORTED IN 2032493-2016-00190 ((B)(4)). NO HARM OR INJURY WAS REPORTED DUE TO THIS INCIDENT.
Patient problems: Aneurysm
MAUDE report 5886245 ↗InjuryAug 18, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM, THE COIL BROKE OR PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE COIL WAS PUSHED OUT TO THE INTENDED SITE USING A SYRINGE. THIS IS 1 OF 2 DEVICES REPORTED DURING THIS INCIDENT. THE OTHER IS REPORTED IN 2032493-2016-00191 ((B)(4)) NO HARM OR INJURY WAS REPORTED DUE TO THIS INCIDENT.
Patient problems: Aneurysm
MAUDE report 5885867 ↗
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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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