Azur Detachable Helical HydroCoil 45-480204Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810170017858), received between Dec 20, 2017 and Apr 28, 2023 — classified as 3 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
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient2
- 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.
MalfunctionApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION FOR A GI BLEED, THE SECOND COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE COIL DEPLOYED IN THE CORRECT SITE AND STAYED IN PLACE. THE PROCEDURE WAS SUCCESSFUL. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16833149 ↗MalfunctionSep 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A PULMONARY VENOUS ARTERIAL MALFORMATION IN THE SUPERIOR RIGHT LOBE, THE COIL DETACHED WITHOUT USE OF THE CONTROLLER IN THE INTENDED TREATMENT SITE. THE COIL WAS POSITIONED CORRECTLY AND WAS LEFT IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7921015 ↗MalfunctionDec 20, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED AS IT WAS ADVANCED OUT OF THE CATHETER. THE COIL WAS LEFT IMPLANTED IN THE INTENDED AREA. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7133929 ↗
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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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