Azur Detachable Helical HydroCoil 45-480405Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810170017896), received between Oct 18, 2018 and Mar 28, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 or Device Component3
- Premature Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Premature Separation; Premature Separation
AS REPORTED IN AN INTERVENTIONAL RADIOLOGY, AN AZUR COIL WAS USED DURING THE PROCEDURE. THE COIL DETACHED SPONTANEOUSLY FROM ITS DELIVERY CATHETER INTO THE MICROCATHETER, WITHOUT MANIPULATION ERROR. THE DEVICE WAS REMOVED, AND A SECOND COIL WAS USED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21724168 ↗MalfunctionMar 30, 2022Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING TREATMENT OF A PSEUDO ANEURYSM, AN EMBOLIZATION IMPLANT COIL DETACHED UNEXPECTEDLY DURING RETRACTION; THE PHYSICIAN WAS INITIALLY NOT SATISFIED WITH THE ORIGINAL POSITIONING. THE SYSTEM WAS REMOVED AND THE CASE COMPLETED SUCCESSFULLY. THE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13956280 ↗MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERIPHERAL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL UNEXPECTEDLY DETACHED FROM ITS DELIVERY SYSTEM PRIOR TO DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10687881 ↗MalfunctionJul 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE EMBOLIZATION COIL DETACHED UNEXPECTEDLY IN THE MICROCATHETER DURING POSITIONING. THE IMPLANT COIL WAS PLACED IN THE INTENDED TREATMENT LOCATION. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10320449 ↗InjuryOct 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING ADVANCEMENT OF THE EMBOLIZATION COIL IN THE MICROCATHETER, THE COIL DETACHED WITHOUT USE OF THE CONTROLLER. TWO (2) ATTEMPTS WERE MADE TO REMOVE THE COIL; HOWEVER, THEY WERE UNSUCCESSFUL. THE COIL WAS LEFT IMPLANTED IN THE HEPATIC ARTERY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE ISSUE. THE PATIENT IS REPORTED TO BE FEELING GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7979373 ↗
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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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