AZUR VACULAR PLUG 45-180500Recalls & reported problems
Microvention, Inc. · AZUR VACULAR PLUG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429101612), received between Sep 24, 2021 and Jan 24, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
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.
InjuryJan 24, 2026Migration
IT WAS REPORTED THAT THE PATIENT WAS SUBMITTED TO A PRE EVAR INFERIOR MESENTERIC ARTERY EMBOLIZATION. THE PLUG SELECTED FOR TREATMENT MIGRATED. A SNARE WAS USED TO REMOVE IT. THE IMA WAS THEN EMBOLIZED WITH COILS. THE PROCEDURE WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174897 ↗InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN AZUR VASCULAR PLUG WAS USED IN A GDA EMBOLIZATION CASE. THE PLUG WAS DEPLOYED WITHOUT ISSUE AND THERE WAS STASIS AT THE END OF THE CASE. TWO WEEKS AFTER IMPLANTATION, THE PATIENT RETURNED FOR A FOLLOW UP AND THE VESSEL WAS NO LONGER OCCLUDED. AN ADDITIONAL EMBOLIZATION WAS REQUIRED TWO WEEKS POST TREATMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12528602 ↗
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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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