AZUR 45-780304-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777024381), received between Jan 18, 2018 and Nov 6, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryNov 6, 2023Migration; Separation Problem; Migration; Separation Problem

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT USED TO TREAT A BLEED WOULD NOT FULLY DETACH WITH THE DETACHMENT CONTROLLER. THE COIL PARTIALLY DEPLOYED AND THEN BECAME DISLODGED, MIGRATING TO A DIFFERENT VESSEL WITHIN THE LIVER. THERE WAS NO REPORTED INJURY OR INTERVENTION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON NOVEMBER 9TH: THERE WAS NO ADVERSE AFFECT TO THE PATIENT AND THEY ARE DOING WELL. THERE ARE NO PLANS TO ADDRESS THE COIL¿S POSITION. A GDA BLEED WAS BEING TREATED. THE COIL DETACHED WHEN IT WAS BEING RETRACTED AND CAUGHT ON THE BASE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080684 ↗
• MalfunctionMay 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A PSEUDOANEURYSM, AN EMBOLIZATION COIL IMPLANT DETACHED WHILE BEING RETRACTED INTO THE CATHETER FOR REPOSITIONING. THE PROGREAT CATHETER WAS REMOVED WITH THE COIL INSIDE OF IT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758663 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ATTEMPT TO ADVANCE THE EMBOLIZATION COIL, THE COIL DETACHED IN THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED FROM THE PATIENT IN THEIR ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712665 ↗
• MalfunctionJan 18, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT SEVERAL COILS HAD BEEN PLACED IN AN ACTIVE GASTROINTESTINAL BLEED. DURING POSITIONING OF THE FINAL COIL, RESISTANCE WAS ENCOUNTERED AND THE COIL WAS WITHDRAWN. DURING REMOVAL, THE COIL FELT "STICKY," AND HALF OF THE COIL DETACHED IN THE MICROCATHETER WITH THE OTHER HALF IN THE INTENDED TREATMENT AREA. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY TOGETHER WITH THE MICROCATHETER AND THE GUIDING CATHETER AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204357 ↗