Azur Detachable Helical HydroCoil 45-452020Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170015038), received between Mar 11, 2025 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Separation
As reported, the patient had an abdominal aortic pseudoaneurysm (diameter: 50 mm). During the procedure, a 5F angiographic catheter was used to deliver the first AZUR 20-30 coil. Significant resistance was encountered during advancement, resulting in separation of the delivery wire from the coil. The angiographic catheter was subsequently withdrawn. A new angiographic catheter was then used, and two AZUR 20-30 coils were successfully delivered without issue. A covered stent was subsequently deployed, and the procedure was completed successfully. The patient returned safely to the ward, and no harm or adverse clinical impact occurred. Patient condition, stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941629 ↗MalfunctionMar 11, 2025Premature Separation; Premature Separation
ADDITIONAL PATIENT DEMOGRAPHIC INFORMATION RECEIVED IN SECTIONS: A2, A3A, A4. SEE H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21579639 ↗
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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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