AZUR VACULAR PLUG 45-180800Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429101629), received between Jul 23, 2021 and Aug 15, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE VASCULAR AZUR PLUG WAS USED IN A RADIAL APPROACH SPLENIC ARTERY BLEED EMBOLIZATION. THE VESSEL MEASURED JUST OVER 6MM AND THE PHYSICIAN DECIDED TO PLACE AN 8MM AZUR PLUG THROUGH A MICROCATHETER. THE PLACEMENT WENT WELL, BUT AFTER A FEW SHOTS, THE PLUG MIGRATED DISTALLY. THE 8MM PLUS EMBOLIZED SAFELY AND REMAINED IN THE PATIENT. THE PHYSICIAN THEN DECIDED TO GO WITH A LARGER 10MM PLUG AND DURING PREPARATION OUTSIDE OF THE BODY, THE 10MM PLUG UNINTENTIONALLY DETACHED RENDERING IT UNUSABLE. THE PHYSICIAN THEN ATTEMPTED TO PLACE MULTIPLE EMBOLIZATION COILS (X6) BUT THE COILS WOULD NOT ADVANCE THROUGH ENTIRE MICROCATHETER. A NEW MICROCATHETER WAS REPLACED AND THE CASE WAS FINISHED SUCCESSFULLY WITH COMPETITOR COILS. THERE WAS NO REPORT OF HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822113 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN PLACED AN 8MM AZUR VASCULAR PLUG IN THE GASTRODUODENAL ARTERY (GDA). WHEN THE PATIENT RETURNED 10 DAYS LATER FOR A Y-90 TREATMENT, IT WAS FOUND THAT THE GDA WAS NOT OCCLUDED. COILS WERE USED TO OCCLUDE THE GDA AND THE Y-90 TREATMENT WAS COMPLETED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543237 ↗
• MalfunctionJul 28, 2021Migration; Migration

  IT WAS REPORTED THAT AN AZUR VASCULAR PLUG WAS USED TO OCCLUDE A PATIENT'S SPLENIC ARTERY. THE VASCULAR PLUG MIGRATED SLIGHTLY DOWNSTREAM, WHICH THE PHYSICIAN WAS "OKAY" WITH AS THEY INTENDED ON OCCLUDING THE ENTIRE ARTERY. THE ARTERY STILL HAD FLOW SO THE OCCLUSION WAS COMPLETED WITH COILS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241480 ↗
• InjuryJul 23, 2021Migration; Migration

  IT WAS REPORTED THAT AN AZUR VASCULAR PLUG WAS USED TO TREAT GDA BLEED. THE PLUG WAS DEPLOYED WITHOUT ISSUE BUT THEN MIGRATED INTO AN ACCESSORY BRANCH. EMBOLIZATION COIL IMPLANTS WERE UTILIZED TO EMBOLIZE THE GDA. ANGIOGRAPHY REVEALED THAT THE AVP HAD MIGRATED TO THE HEPATIC ARTERY. A SNARE WAS USED TO RETRIEVE THE PLUG, BUT IT WAS ULTIMATELY UNSUCCESSFUL. THE PLUG WAS LEFT IN THE HEPATIC ARTERY, WHICH STILL HAD FLOW, ORIENTED IN A "NORTH-SOUTH" POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222189 ↗