AZUR 45-780202-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816777024367), received between Aug 24, 2017 and Mar 25, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WOULD NOT DETACH WITH TWO DIFFERENT DETACHMENT CONTROLLERS. IT WAS THEN NOTICED THAT THE COIL HAD UNEXPECTEDLY DETACHED. THE PATIENT WAS REPORTED TO BE "FINE AND IT WAS A SUCCESSFUL PROCEDURE." THE COIL WAS IN APPROPRIATE POSITION WHEN DETACHMENT WAS ATTEMPTED SO IT WAS LEFT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684185 ↗
• MalfunctionMar 22, 2026Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN POSITIONED THE COIL AND, UPON ATTEMPTING TO DEPLOY IT, OBSERVED A RED LIGHT ON THE DETACHMENT HANDLE. THE PHYSICIAN WIPED THE HANDLE AND ATTEMPTED DEPLOYMENT AGAIN, WITH THE SAME RED-LIGHT RESPONSE. A SECOND DETACHMENT HANDLE WAS USED, BUT THE SAME RED LIGHT OCCURRED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, IT WAS DISCOVERED THAT THE COIL HAD IN FACT DETACHED, ALTHOUGH NO GREEN LIGHT OR DEPLOYMENT LIGHT SEQUENCE WAS OBSERVED ON THE HANDLE. IT WAS REPORTED THAT THE EVENT DID NOT AFFECT THE PATIENT. THE COIL WAS DEPLOYED IN THE INTENDED LOCATION, AND THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24658911 ↗
• MalfunctionApr 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING RE-POSITIONING OF THE COIL IN THE INTENDED TREATMENT AREA, THE COIL DETACHED WITHOUT USE OF THE V-GRIP CONTROLLER. THE COIL REMAINS IMPLANTED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567530 ↗
• MalfunctionAug 24, 2017Detachment Of Device Component; Kinked; Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL, THE COIL UNEXPECTEDLY DETACHED AND KINKED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819653 ↗
• MalfunctionAug 24, 2017Detachment Of Device Component; Kinked; Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL, THE COIL UNEXPECTEDLY DETACHED AND KINKED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819651 ↗