AZUR 45-780308-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816777024398), received between Sep 14, 2019 and Jan 8, 2026 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Premature Separation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY DURING THE COIL RELEASE AND THE COIL WAS NOT IMPLANTED IN THE CORRECT LOCATION. THE COIL WAS LOCATED IN THE CATHETER, WHICH WAS ABLE TO BE REMOVED. DURING THE PROCEDURE, OTHER COILS FROM THE SAME LOT WERE SUCCESSFULLY IMPLANTED USING THE SAME DETACHMENT HANDLE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016497 ↗
• InjuryJun 9, 2025Loose or Intermittent Connection; Difficult to Advance; Premature Separation; Loose or Intermittent Connection; Difficult to Advance; Premature Separation

  AS REPORTED, DURING COIL EMBOLIZATION OF A BRANCH OF THE RIGHT EXTERNAL CAROTID ARTERY FEEDING AN OROPHARYNGEAL TUMOR IN THE INTERVENTIONAL RADIOLOGY ROOM, MEDICAL TEAM MEMBERS INTRODUCED THE EMBOLIZATION COIL INTO THE MICROCATHETER. A PREMATURE FRAGMENTATION OF THE COIL SUPPORT WAS THEN OBSERVED, MANIFESTED BY A SEPARATION OF THE SUPPORT WIRE INTO THREE DISTINCT BRANCHES BEFORE ANY DEPLOYMENT OR RELEASE OF THE DEVICE. THIS ABNORMAL DISINTEGRATION, WHICH OCCURRED WHEN THE COIL WAS ONLY INSERTED AND NOT YET DEPLOYED, PREVENTED THE NORMAL PROGRESS OF THE PROCEDURE. THE COIL WAS REMOVED AND USE OF ANOTHER. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172919 ↗
• InjuryJan 25, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE USING A EMBORRHOID TECHNIQUE, THE COIL WAS WELL PLACED AND PACKED WITH PREVIOUS COILS, BUT THE PUSHER WAS NOT ABLE TO BE REMOVED. THE COIL WAS ATTEMPTED TO BE RECAPTURED, BUT THE COIL COULD NOT BE RETRACTED INTO THE CATHETER WHERE IT BECAME STUCK. THE COIL WAS ATTEMPTED TO BE DETACHED BY PULLING ON IT, BUT THE PREVIOUS COILS WERE ALSO STUCK. THE PHYSICIAN MANAGED TO REMOVE THE COIL WITH IT REMAINING OUTSIDE THE CATHETER AND PACKED. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT STATED THERE WAS NO INTERVENTION REQUIRED TO REMOVE THE DEVICE. THE COIL PACK KEPT IN PLACE. THE CASE WAS COMPLETED BY STOPPING THE INTERVENTION AFTER REMOVAL OF THE PACKED COIL DUE TO ARTERY SPASM. PATIENT IS OK AND WILL BE RETREATED IN A FEW WEEKS.

  Patient problems: Vasoconstriction

  MAUDE report 21236663 ↗
• MalfunctionOct 31, 2024Premature Separation; Premature Separation

  AS REPORTED, THE COIL DETACHED WHEN IT WAS PUSHED OUT INTO THE PATIENT FROM THE CATHETER. NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20584499 ↗
• MalfunctionAug 7, 2024Premature Separation; Premature Separation

  IT WAS REPORTED DURING A COIL EMBOLIZATION PROCEDURE, THE IMPLANT HAD RESISTANCE WHEN ADVANCING INSIDE THE CATHETER. THEY ATTEMPTED TO DEPLOY THE COIL BY FLUSHING THE CATHETER WITH NORMAL SALINE AND USED A PUSHER WIRE TO ADVANCE THE COIL. WHEN THE PUSHER WIRE WAS PULLED BACK TO REMOVE THE COIL, IT PREMATURELY DETACHED WITHIN MICROCATHETER. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. WHILE OUTSIDE THE PATIENT, THE COIL WAS STILL UNABLE TO BE DEPLOYED FROM THE CATHETER. FINALLY, THEY BACK LOADED THE WIRE INTO THE CATHETER AND WERE ABLE TO PUSH THE COIL OUT. THE COIL WAS DISCARDED. THEN, THE SAME CATHETER WAS INTRODUCED TO GAIN ACCESS AND COMPLETE THE PROCEDURE. THE PATIENT RECOVERED AND WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935403 ↗
• MalfunctionJun 8, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL WAS UNABLE TO DETACH USING TWO DIFFERENT DETACHMENT CONTROLLERS AS THEY DISPLAYED A FLASHING RED LIGHT. THE COIL WAS ATTEMPTED TO BE REMOVED, BUT IT PREMATURELY DETACHED AND REMAINED IMPLANTED IN A LOCATION THAT WAS NOT IDEAL, BUT ACCEPTABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED. THIS EVENT HAD NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494832 ↗
• MalfunctionFeb 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A LEFT INTERNAL MAMMARY ARTERY COLLATERAL, THE COIL IMPLANT BECAME DETACHED UNEXPECTEDLY IN THE COLLATERAL. THERE WAS NO PATIENT INJURY OR INTERVENTION. IT WAS REPORTED THAT THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595788 ↗
• InjurySep 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT BECAME DETACHED PREMATURELY IN THE MICROCATHETER. THE COIL WAS REMOVED WITH A SNARE. UPON ITS REMOVAL, IT DRAGGED WITH IT ANOTHER COIL THAT WAS PREVIOUSLY SUCCESSFULLY PLACED IN THE ANEURYSM, AND BOTH WERE REMOVED TOGETHER. THE PATIENT DID NOT EXPERIENCE ANY REPORTED SEQUELAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9056719 ↗