Azur CX Detachable 45-782040Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810170018404), received between Nov 8, 2017 and Sep 14, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 23048034 ↗
• InjuryApr 24, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A SPLENIC ANEURYSM EMBOLIZATION, THE COIL BECAME UNATTACHED IN THE 4F 100CM CATHETER. THE COILS WAS SUCCESSFULLY REMOVED USING A SNARE. MULTIPLE COILS WERE SUCCESSFULLY PLACED BOTH BEFORE AND AFTER. THE HOOP WAS FLUSHED PRIOR TO INSERTION AND THERE WAS NO RESISTANCE TO THE COIL BEING PLACED INTO THE CATHETER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177196 ↗
• MalfunctionJul 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED DURING RETRACTION THROUGH THE MICROCATHETER. THE MICROCATHETER HAD TO BE REPOSITIONED, SO THE COIL HAD TO BE RESHEATHED. IT WAS NOT CLEAR IF THE COIL DETACHED IN THE MICROCATHETER OR IN ITS OWN SHEATH. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105753 ↗
• MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A TYPE II ENDOLEAK, THE EMBOLIZATION COIL UNEXPECTEDLY DETACHED IN THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN TRIED FLUSHING AND PUSHING THE COIL INTO THE SAC BUT WAS NOT ABLE TO GET ALL OF THE COIL WHERE IT WAS DESIRED AND THE TAIL END WAS PROTRUDING OUT IN THE VESSEL. THE CASE WAS ABANDONED AND THE PATIENT WAS DOING FINE. NO FURTHER INTERVENTION WAS PLANNED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062914 ↗
• MalfunctionDec 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION PROCEDURE, THE COIL WOULD NOT ADVANCE AND DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10932475 ↗
• InjurySep 13, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A SPLENIC ARTERY ANEURISM, THE IMPLANT COIL BECAME STUCK IN THE MICROCATHETER. STRONGER FORCE WAS PLACED IN THE DEVICE IN ORDER TO ADVANCE IT, BUT IT WOULD NOT ADVANCE. DURING ATTEMPTS TO WITHDRAW THE DEVICE AND MICROCATHETER TOGETHER, THE IMPLANT COIL BECAME DETACHED. A SNARE WAS USED TO RETRIEVE THE IMPLANT COIL. THE PATIENT DID NOT EXPERIENCE ANY REPORTED SEQUELAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9050528 ↗
• MalfunctionMay 31, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SPLENIC ARTERY EMBOLIZATION TREATMENT, THE COIL GOT STUCK INSIDE THE CATHETER AND DETACHED. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THE CATHETER WAS FLUSHED AFTER REMOVAL FROM THE PATIENT, AND THE COIL CAME OUT. 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 8660369 ↗
• MalfunctionJun 13, 2018Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position

  IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO POSITION THE COIL. 1/2 OF THE COIL WAS POSITIONED; HOWEVER, THE COIL WAS UNABLE TO ADVANCE FURTHER AND DETACHED IN THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599254 ↗
• MalfunctionNov 8, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING PLACEMENT OF THE 6TH EMBOLIZATION COIL IN THE DISTAL SPLENIC ARTERY. THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED INTO THE INTENDED AREA WITH A GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7009507 ↗