AZUR VACULAR PLUG 45-181000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842429101636), received between Mar 4, 2022 and Dec 10, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Migration; Migration

  NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772026 ↗
• InjuryJul 16, 2024Migration; Migration

  IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE, THE NOTED 10MM AZUR VASCULAR PLUG MIGRATED FROM INITIAL DEPLOYMENT LOCATION UPON BEING DETACHED FROM PUSHER WIRE. THE PLUG TRAVELLED FROM PROXIMAL SPLENIC INTO THE HILUM OF THE PATIENT. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757004 ↗
• MalfunctionOct 25, 2022Migration; Migration

  IT WAS REPORTED THAT AN AZUR VASCULAR PLUG WAS USED TO TREAT A SPLENIC ARTERY. THE 10MM AVP WAS DEPLOYED WITHOUT ISSUE BUT THEN MIGRATED IN THE VESSEL. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT. THE PATIENT CONDITION WAS STABLE, AND THE PROCEDURE OUTCOME SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671574 ↗
• InjuryOct 24, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE WITH AN AZUR VASCULAR PLUG. THE VASCULAR PLUG WAS OBSERVED TO HAVE MIGRATED APPROX 5-7MM FROM THE ORIGINAL POSITION AND ADDITIONAL COILS WERE PLACED AT THE PROXIMAL SECTION. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658110 ↗
• InjuryMay 12, 2022Migration; Migration

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF THE SPLENIC ARTERY, AN AZUR VASCULAR PLUG (AVP) ENCOUNTERED ADVANCEMENT ISSUES BUT WAS EVENTUALLY DEPLOYED. IMMEDIATELY FOLLOWING DEPLOYMENT, THE DEVICE MIGRATED DISTALLY TO A VESSEL CLOSE TO THE SPLEEN. ANOTHER AVP WAS SUCCESSFULLY USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14383305 ↗
• InjuryMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE THE AZUR VASCULAR PLUG WAS PLACED IN THE PROXIMAL SPLENIC ARTERY JUST DISTAL TO A 3CM ANEURYSM. AFTER ABOUT 5 MINUTES OF ELAPSED TIME, THE PLUG MIGRATED FORWARD TO THE DISTAL SPLENIC ARTERY. ADDITIONAL COILS WERE PLACED IN THE PROXIMAL SPLENIC ARTERY AND OCCLUSION WAS ACHIEVED. THE SPLENIC ARTERY MEASURED 7MM ON CTA. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT. THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U.S. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939899 ↗
• MalfunctionMar 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A PARTIAL SPLENIC EMBOLIZATION COIL, AN AZUR VASCULAR PLUG WAS IMPLANTED. EIGHT MINUTES AFTER IMPLANTATION, THE PLUG WAS OBSERVED TO HAVE MOVED 1-2 CM FROM THE ORIGINAL POSITION. THE CASE WITH SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665098 ↗