AZUR 45-880005Recalls & reported problems
Microvention, Inc. · AZUR HydroPack 18 · Class 2 · Implant
All models of AZUR (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429118030), received between Nov 17, 2025 and Nov 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Premature Separation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2025Premature Separation; Premature Separation
AS REPORTED, THE AZUR HYDROPACK COIL DETACHED PREMATURELY INSIDE THE PATIENT. THE PHYSICIAN SNARED THE COIL OUT ON THE FIRST TRY. THERE WERE NO COMPLICATIONS. THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS REPORTED AS SUCCESSFUL. THE DEVICE IS NOT AVAILABLE FOR RETURN AND ANALYSIS. TYPE OF CASE WAS PAVM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23573148 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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