Azur Detachable Framing Coil 45-651026Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810170016103), received between Apr 7, 2016 and Dec 26, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS ATTEMPTED IN AN ANEURYSM ON A PATIENT WITH A TYPE II ENDOLEAK. AN ATTEMPT TO PLACE THE 2ND COIL WAS NOT SUCCESSFUL AND DURING RETRACTION, THE COIL STRETCHED INTO A "HAIR THIN WIRE" AND BECAME STUCK "WHERE THE GRAFT MET THE SAC," SO IT COULD NOT BE REMOVED FROM THE CATHETER. ALL ACCESS AND DELIVERY SYSTEM DEVICES WERE REMOVED FROM THE PATIENT AND A SURGICAL FEMORAL CUT DOWN WAS PERFORMED. THE WIRE WAS THEN PULLED WITH EXCESSIVE FORCE AND THE WIRE CAME FREE. THE ARTERIOTOMY WAS CLOSED AND THE PATIENT DID WELL IN RECOVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197278 ↗
• InjuryApr 8, 2016Device Issue; Detachment of Device or Device Component; Device Issue; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. AN ATTEMPT WAS MADE TO CATCH THE COIL UNSUCCESSFULLY. A PORTION OF THE COIL REMAINED WITHIN THE PARENT ARTERY, RIGHT ACOM. IT WAS REPORTED THAT THERE WAS NO OTHER COMPLICATION. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5564444 ↗
• MalfunctionApr 7, 2016Device Issue; Detachment of Device or Device Component; Device Issue; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, IN AN ATTEMPT TO "FORCE" THE COIL THROUGH THE TORTUOSITY OF THE VASCULATURE, THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE COIL WAS REMOVED SUCCESSFULLY WITH THE MICROCATHETER. ADDITIONAL COILS WERE DEPLOYED SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS INCURRED AS A RESULT OF THIS COMPLAINT.

  Patient problems: Aneurysm

  MAUDE report 5559625 ↗