Azur CX Detachable 45-781639Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170018381), received between Apr 20, 2022 and Feb 24, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Physical Resistance/Sticking

  AS REPORTED: WHEN TREATING A SPLENIC ARTERY ANEURYSM, THEY PROBED INTO THE ANEURYSM WITH A 90CM GUIDING SHEATH AND A 2.7FR MICROCATHETER. EVERYTHING WENT WELL AND THEY WERE ABLE TO PLACE 5 FRAMING COILS. AFTERWARDS, THEY WANTED TO FILL IT WITH CX COILS, BUT THE COIL WOULD NOT COME OUT OF THE MICROCATHETER AND KEPT GETTING STUCK. REGARDING THE MICROCATHETER, THERE IS NO COMPLAINT ABOUT IT, AS WIRES ETC. COULD BE PUSHED THROUGH WITHOUT ANY PROBLEMS. FLUSHING WAS ALSO NO PROBLEM. IN THE END, THE ANEURYSM WAS NOT FILLED FURTHER, BUT LEFT WITH THE COILS THAT HAD ALREADY BEEN IMPLANTED. UNFORTUNATELY, THE CASE WAS NOT COMPLETED SATISFACTORILY ¿ THEY STOPPED THE PROCEDURE WHEN THE COIL WOULDN'T PASS THROUGH THE MICROCATHETER, BUT THEY WOULD HAVE LIKED TO CONTINUE FILLING WITH COIL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429963 ↗
• MalfunctionSep 14, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT UPON GAINING ACCESS TO THE ANEURYSM, THE COIL WAS PREPPED AND INTRODUCED INTO THE MICROCATHETER AND WHEN IT ENCOUNTERED THE GENTLE CURVES OF THE SPLENIC ARTERY IT BEGAN TO BIND. THE COIL WAS REMOVED AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN WAS ABLE TO REMOVE 1/3 OF THE COIL OUT, BUT UPON ATTEMPT TO POSITION THE COIL, IT BECAME DETACHED FROM THE PUSHER WIRE. THE ENTIRE MICRO SYSTEM WAS REMOVED. IT WAS REPORTED THAT THIS ISSUE OCCURRED WITH THREE SEPARATE COILS DURING THE CASE. THE PHYSICIAN SWITCHED TO A COMPETITOR'S COILS AND WAS ABLE TO SUCCESSFULLY TREAT THE ANEURYSM. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT RECOVERED WELL WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048195 ↗
• InjuryMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED: DURING EMBOLIZATION PSEUDOANEURYSM THE ¿COIL SPLIT IN TWO IN THE PROGREAT MICROCATHETER WHEN DEPLOYED. THEY WERE ABLE TO PULL THE MICROCATHETER OUT WITH THE HALF OF THE COIL STILL INSIDE¿. IT IS THE UNDERSTANDING THAT THE COIL BROKE IN TWO AFTER IT WAS DETACHED. WHEN PULLING BACK ON THE PUSHER WIRE UNDER FLURO, THEY NOTICED HALF OF THE COIL STILL IN THE MICROCATHETER. THEY PUSHED THE COIL OUT INTO THE ANEURYSM WITH A WIRE AND WENT ABOUT THE REST OF THE CASE. IT IS NOTED THAT THE PATIENT IS STABLE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986586 ↗
• MalfunctionApr 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER WHEN THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK INTO THE MICROCATHETER FOR RE-POSITIONING. THE MICROCATHETER WITH COIL WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER SET OF MICROCATHETER AND COIL WERE USED TO COMPLETE THE CASE SUCCESSFULLY. LESS THAN 250CC ESTIMATED BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161974 ↗