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Azur Detachable Helical HydroCoil 45-450415Recalls & 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 00810170014901), received between Nov 8, 2016 and Apr 5, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

  • Detachment Of Device Component1
  • Detachment of Device or Device Component1
  • Device-Device Incompatibility1
  • Difficult or Delayed Positioning1
  • Difficult to Advance1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 5, 2019Difficult or Delayed Positioning; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult or Delayed Positioning; Detachment of Device or Device Component; Device-Device Incompatibility

    IT WAS REPORTED THAT DURING A TIPS PROCEDURE, THE COIL DID NOT TAKE SHAPE RIGHT AWAY AS IT WAS ADVANCED INTO A VARIX. THE COIL WAS ALLOWED TO SOFTEN AND THE COIL TOOK SHAPE NICELY DURING THE SECOND ATTEMPT; HOWEVER, THE LAST PORTION OF THE COIL COULD NOT BE ADVANCED OUT OF THE CATHETER TIP. THE COIL WAS PULLED AND PUSHED "FAIRLY HARD," HOWEVER, IT WOULD NOT ADVANCE OUT OF THE CATHETER. THE PUSHER WIRE WAS REMOVED AND THEN THE ENTIRE SYSTEM WAS REMOVED. UPON INSPECTION OUTSIDE THE PATIENT, THE COIL WAS NOTED TO HAVE DETACHED IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8487998 ↗
  • InjuryNov 8, 2016Detachment Of Device Component; Difficult to Advance; Detachment Of Device Component; Difficult to Advance

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL SEPARATED FROM THE DELIVERY PUSHER. THE COIL WAS RETRIEVED USING A WIRE, HOWEVER, PART OF THE WIRE BROKE. THE COIL AND WIRE WERE REMOVED SUCCESSFULLY USING AN ENDOVASCULAR SNARE. THE CASE WAS CONTINUED USING ADDITIONAL COILS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6087930 ↗

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Sources and updates

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