Azur Detachable Framing Coil 45-682050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810170017834), received between Nov 14, 2016 and Jun 17, 2026 — classified as 1 injury, 7 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.

• MalfunctionJun 17, 2026Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS BEING USED IN A GDA EMBOLIZATION PROCEDURE. REPORTEDLY DURING ADVANCING THE COIL IN THE MICROCATHETER, THE COIL PREMATURELY DETACHED PRIOR TO PLACEMENT IN INTENDED SITE. IT WAS UNKNOWN WHETHER THE COILS DETACHED AT THE HUB OR MORE DISTAL IN THE MICROCATHETER. THE SAME NON TERUMO NEURO CATHETER WAS USED WITH ALL THREE COILS. THE COIL AND CATHETER WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL AT THE END OF THE PROCEDURE. THIS IS EVENT REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540879 ↗
• MalfunctionFeb 11, 2026Physical Resistance/Sticking; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319189 ↗
• MalfunctionFeb 11, 2026Physical Resistance/Sticking; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317979 ↗
• MalfunctionSep 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481142 ↗
• MalfunctionDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10953717 ↗
• InjurySep 11, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A SPLENIC ARTERY ANEURYSM. THE EMBOLIZATION COIL FORMED AS INTENDED IN THE ANEURYSM AND WAS DEPLOYED. AFTER DEPLOYMENT, IT APPEARED THAT THE COIL APPEARED TO BE "FUSED" AT THE DISTAL TIP OF THE MICROCATHETER. THE MICROCATHETER WAS MANIPULATED TO MANUALLY FREE THE COIL, BUT THE COIL WOULD NOT RELEASE FROM THE TIP AND IT COULD NOT BE PUSHED OUT. DURING AN ATTEMPT TO REMOVE THE MICROCATHETER AND COIL TOGETHER, THE COIL DETACHED IN THE GUIDE CATHETER AND BECAME UNWOUND AND LEFT BEHIND IN THE SPLENIC ARTERY AND AORTA. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE COIL WITH A SNARE DEVICE. THE SPLENIC ARTERY BECAME PERFORATED AND THE PATIENT WAS TAKEN TO THE OR FOR SURGICAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "STABLE."

  Patient problems: Perforation of Vessels

  MAUDE report 10525827 ↗
• MalfunctionMar 16, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A FISTULA OFF THE LEFT MAIN BRANCH TO THE CORONARY SINUS, THE COIL WAS ADVANCED TO THE DISTAL PART OF THE FISTULA. THE DISTAL PORTION OF THE COIL ADVANCED BEYOND A PREVIOUSLY IMPLANTED AMPLATZER VASCULAR PLUG (AVP); THEREFORE, THE COIL WAS PULLED BACK TO REPOSITION IT. TENSION ON THE PUSHER WIRE WAS ENCOUNTERED, AND THE COIL DETACHED INSIDE THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426936 ↗
• MalfunctionNov 14, 2016Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL ENCOUNTERED RESISTANCE WITHIN THE MICROCATHETER AS TORTUOUS ANATOMY WAS STATED. ATTEMPTS WERE MADE TO PUSH AND PULL THE DEVICE. DURING THE ATTEMPTED POSITIONING, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER PARTIALLY WITHIN THE VESSEL AND THE MICROCATHETER. THE ENTIRE SYSTEM WAS WITHDRAWN WITHOUT INCIDENT. NO INTERVENTION WAS TAKEN, NO PATIENT INJURY WAS INCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6100658 ↗