AZUR 45-780204-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00816777024374), received between Nov 9, 2020 and Jun 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY. THE COIL WAS IN SATISFACTORY POSITION; THERE WERE NO COMPLICATIONS AND THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642002 ↗
• MalfunctionSep 4, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING A Y90 TREATMENT, COIL WAS ATTEMPTED TO BE PLACED THROUGH A MICROCATHETER. COIL TESTED GREEN OUTSIDE OF BODY WITH CONTROLLER, BUT ONCE PLACED WOULD NOT DEPLOY, RED ON CONTROLLER. COIL WAS WIPED WITH A DRY GAUZE. MULTIPLE CONTROLLERS WERE OPENED. THE COIL PRE-DETACHED, SO IT WAS DEPLOYED. THE COIL DETACHED IN THE CORRECT LOCATION, WIRE HELPED PUSH IT TO THE CORRECT SPOT. CASE WAS COMPLETED WITH ANOTHER COIL. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22966770 ↗
• MalfunctionJan 29, 2025Premature Separation; Premature Separation

  IT WAS REPORTED ONLY " TIP BROKE/DEFECTIVE¿. NO DATE OF INCIDENT OR DETAILS WERE PROVIDED. IT IS NOTED THE EVENT OCCURRED INTRA-OPERATIVE AND TYPE OF PROCEDURE PERFORMED WAS AN "EMBO". IT IS ALSO NOTED AS A MALFUNCTION ONLY AND NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL CASE INFORMATION WERE MADE, HOWEVER, TO DATE, NO CLARIFICATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267032 ↗
• MalfunctionJul 3, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL COULD NOT DETACH USING TWO DIFFERENT DETACHMENT CONTROLLERS AS THEY DISPLAYED A RED LED LIGHT. A THIRD ATTEMPT WAS MADE TO DETACH THE COIL WITH A DIFFERENT DETACHMENT CONTROLLER, BUT IT HAD NO SUCCESS. WHILE ATTEMPTING TO RECOVER THE COIL AT THE TREATMENT SITE, IT PREMATURELY DETACHED FROM THE PUSHER INTO THE INTENDED LOCATION AND WAS IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED. THERE WAS NO INTERVENTION, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672235 ↗
• MalfunctionMar 8, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL COULD NOT ADVANCE PAST THE DISTAL PART OF THE MICROCATHETER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, IT PREMATURELY DETACHED. THE COIL WAS ABLE TO BE PUSHED INTO THE VESSEL USING AN ALTERNATIVE COIL PUSHER WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT'S CONDITION AND OUTCOME WERE NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871698 ↗
• MalfunctionDec 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT BECAME DETACHED WITHIN THE MICROCATHETER DURING ADVANCEMENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085524 ↗
• MalfunctionNov 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS PASSED THROUGH A MICROCATHETER CATHETER FINE AND TRACKED INTO POSITION AND WAS DETACHED PER USUAL TECHNIQUE. HOWEVER, WHEN REMOVING THE PUSHER WIRE, A PORTION OF THE COIL TRACKED BACK INTO THE MICROCATHETER. REPORTEDLY, THE PHYSICIAN WAS ABLE TO PLACE THE COIL IN POSITION IN THE PATIENT. THERE WAS NO REPO OF HARM OR INJURY TO THE PATIENT, WHO WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807875 ↗
• MalfunctionAug 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY IN THE MICROCATHETER DURING A TREATMENT FOR A PULMONARY ARTERIOVENOUS MALFORMATION. THE COIL WAS ADVANCED OUT OF THE MICROCAHTETER AND COULD NOT BE RECAPTURED. IT WAS THE FIRST COIL IN THE CASE AND THE PHYSICIAN WAS ABLE TO SECURE AND STABILIZE THE IMPLANT COIL WITH OTHER SUBSEQUENT COILS. THE PROCEDURE WAS COMPLETED, BUT NO ABILITY TO READJUST THE COIL. THE PATIENT IS "STABLE". THERE WAS NO PATIENT INJURY NOR MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340515 ↗
• MalfunctionNov 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A RIGHT RENAL ARTERY, THE EMBOLIZATION COIL DID NOT ADVANCE, AND THEN DETACHED IN THE CATHETER AS IT WAS BEING WITHDRAWN. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY, OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10813537 ↗