Azur CX Detachable 45-750511Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00812636021027), received between Nov 30, 2016 and Feb 27, 2026 — classified as 3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Premature Separation

  IT WAS REPORTED THAT: DURING A DIGESTIVE EMBOLIZATION, THE COIL DETACHED ON ITS OWN IN THE TUBE / MICROCATHETER DURING USE INSIDE THE PATIENT DURING PLACEMENT. THE COIL WAS REMOVED WITH THE MICROCATHETER. NO INTERVENTION WAS USED TO REMOVE THE COIL. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472092 ↗
• MalfunctionNov 29, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT PRIOR TO PLACING THE GORE ENDOGRAFT, THE PHYSICIAN WANTED TO COIL THE IMA TO PREVENT THE POTENTIAL OUTCOME OF A TYPE 2 ENDOLEAK LATER DOWN THE ROAD. THE VESSEL MEASURED 4MM, SO WE DECIDED TO GO WITH THE 5X11 .035 COIL. HE WASN'T 100 PERCENT HAPPY WITH THE DISTAL PLACEMENT OF THE COIL, SO THE PHYSICIAN WAS MOVING IT BACK AND FORTH SO IT WOULD FORM PROXIMAL TO THE BIFURCATION. AFTER PULLING THE COIL BACK IN ON THE THIRD TRY, THE COIL DETACHED ON ITS OWN, SO WE HAD TO COMMIT TO IT. HALF OF THE COIL WAS STILL IN THE GLIDECATH AND SALINE WAS USED TO FLUSH THE COIL INTO THE SAC AND ALL WAS GOOD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675941 ↗
• MalfunctionFeb 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORT THAT DURING AN EMBOLIZATION TREATMENT, THE COIL PREMATURELY DETACHED WITHIN THE CATHETER. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586856 ↗
• MalfunctionJun 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE VASCULAR EMBOLIZATION COIL IMPLANT WAS USED IN A SPLENIC EMBOLIZATION PROCEDURE WHEN THE COIL UNEXPECTEDLY DETACHED WITHOUT USE OF A DETACHMENT CONTROLLER. WHEN THE PUSHER WIRE WAS REMOVED, A SMALL FILAMENT CAME OUT OF THE CATHETER. THE PUSHER WIRE WAS REMOVED AND A WIRE WAS USED TO PUSH IT OUT BUT IT WOULD NOT ADVANCE THROUGH THE CATHETER. REPORTEDLY, THE PATIENT IS STABLE AND UNAFFECTED AND THE EMBOLIZATION PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072077 ↗
• MalfunctionApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A RIGHT SUBCLAVIAN ANEURYSM, AN EMBOLIZATION COIL IMPLANT WAS HALFWAY DEPLOYED WHEN THE CATHETER LOST POSITION. THE COIL AND CATHETER WERE REMOVED IN THEIR ENTIRETY. IT WAS OBSERVED THAT THE IMPLANT HAD DETACHED FROM THE DELIVERY PUSHER INSIDE OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632253 ↗
• InjuryAug 22, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING RETRACTION INTO A MICROCATHETER FOR REPOSITIONING, AN EMBOLIZATION COIL BEGAN TO STRETCH. UPON ADVANCEMENT INTO THE VESSEL, THE IMPLANT COIL DETACHED. THE IMPLANT WAS SUSPENDED IN THE AORTA AND WAS RETRIEVED WITH A SNARE. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF EMBOLIZATION COIL; THE PHYSICIAN CONTINUED TO ADVANCE THE DEVICE, AND THE IMPLANT DETACHED FROM THE DELIVERY PUSHER. THE IMPLANT WAS REMOVED BY HAND. THERE WAS NO REPORTED ADVERSE CLINICAL SEQUELA TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8922049 ↗
• InjuryJul 26, 2019Difficult or Delayed Positioning; Detachment of Device or Device Component; Migration; Difficult or Delayed Positioning; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A LOWER ARM FISTULA TO EMBOLIZE A COLLATERAL VESSEL THAT WAS STEALING FLOW. AN ATTEMPT WAS MADE TO RETRACT THE COIL INTO THE CATHETER AND REPOSITION IT AFTER A FEW CENTIMETERS OF THE COIL HAD BEEN DEPLOYED; HOWEVER, THE COIL DETACHED FROM THE PUSHER WHILE THE IMPLANT COIL WAS STILL PARTIALLY IN THE CATHETER. THE COIL THEN MIGRATED OUTSIDE THE CATHETER INTO THE FISTULA. ATTEMPTS TO SNARE THE DETACHED COIL WERE UNSUCCESSFUL. A DIALYSIS CATHETER WAS INSERTED AS A TEMPORARY SOLUTION FOR DIALYSIS, AS THE FISTULA WAS NO LONGER VIABLE AND THE VESSELS WERE TOO SMALL FOR A STENT GRAFT PLACEMENT. THE FINAL ANGIOGRAM DID NOT DEMONSTRATE CLOT; HOWEVER, IT WAS BELIEVED THAT THE LOCATION OF THE DETACHED COIL WOULD ENSURE THAT THE FISTULA WOULD CLOT OVER TIME AND AN UPPER ARM FISTULA WILL EVENTUALLY BE CREATED.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 8832635 ↗
• MalfunctionMar 2, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING AN EMBOLIZATION COIL IN THE MICROCATHETER. DURING WITHDRAWAL, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED INTO THE INTENDED AREA WITH A SALINE INJECTION. 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 7311573 ↗
• InjuryMar 2, 2018Detachment Of Device Component; Difficult to Remove; Device-Device Incompatibility; Detachment Of Device Component; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING AN EMBOLIZATION COIL IN THE MICROCATHETER. DURING WITHDRAWAL, THE COIL DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED; HOWEVER, 1/2 OF THE COIL REMAINED IN THE TARGET AREA AND 1/2 OF THE COIL REMAINED IN THE PARENT VESSEL. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE COIL WITH A SNARE DEVICE; HOWEVER, THEY WERE UNSUCCESSFUL. THE DECISION WAS MADE TO LEAVE THE COIL IN POSITION IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311568 ↗
• MalfunctionNov 30, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE AZUR EMBOLIZATION COIL DETACHED IN THE MICROCATHETER. HALF OF THE COIL EXTENDED OUTSIDE THE MICROCATHETER AND HALF OF THE COIL REMAINED INSIDE THE MICROCATHETER. SEVERAL ATTEMPTS WERE MADE TO PUSH THE DETACHED COIL OUT OF THE MICROCATHETER; HOWEVER, THEY WERE UNSUCCESSFUL. THE MICROCATHETER, DELIVERY SYSTEM, AND THE ENTIRE COIL WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6136943 ↗