Azur CX Detachable 45-751632Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00812636021096), received between Jan 2, 2017 and Jun 2, 2026 — classified as 5 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Premature Separation

  AS REPORTED: CARTO PROCEDURE STARTED WITH LARGE 0.035 COILS WHICH WERE SUCCESSFULLY DEPLOYED WITH NO PROBLEMS THROUGH THE BASE CATHETER. OPERATOR BEGAN TO STEP DOWN IN SIZE WHEN THE 16X32 0.035 CX IN QUESTION WAS PULLED. PREP OF THE COIL WAS PERFORMED WITH NO ISSUES, BASE CATHETER WAS FLUSHED AND COIL WAS INSERTED INTO BASE CATHETER. THE COIL WAS TRACKING ADEQUATELY THROUGH THE TORTUOUS ANATOMY UNTIL RESISTANCE WAS MET. AFTER MANIPULATING THE COIL AND SEVERAL ATTEMPTS TO ADVANCE THE COIL, IT APPEARED TO DETACH FROM THE PUSHER WIRE. OPERATOR REMOVED THE CATHETER ENTIRELY TO SAFELY REMOVE THE COIL. NO HARM TO THE PATIENT, NEW BASE CATHETER WAS ADVANCED, AND COILING RESUMED WITH NO FURTHER ISSUES. DID NOT RECOVER THE COIL AS IT WAS LODGED INSIDE THE BASE CATHETER. OVERALL CASE WAS SUCCESSFUL AND OPERATOR WAS VERY PLEASED WITH THE OUTCOME. COIL IN QUESTION NEVER LEFT THE CATHETER HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366028 ↗
• InjuryNov 12, 2025Unraveled Material; Migration; Difficult or Delayed Separation; Unraveled Material; Migration; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING TRANSCAVAL TYPE II EMBOLIZATION, WE DEPLOYED SEVERAL COILS WITHIN THE ANEURYSM SAC. ON OUR LAST COIL, THE PHYSICIAN FELT THE COIL WASN'T RESPONDING THE WAY HE THOUGHT IT SHOULD AND THAT IT HAD PREMATURELY DETACHED. I LET HIM KNOW THAT THE COIL WAS STILL MOVING WITH THE PUSHES/PULLS OF THE DEVICE THAT HE WAS DOING. HE DID NOT ATTACH THE DETACHMENT CONTROLLER AND DID NOT PULL BACK SLOWLY TO CHECK IF IT HAD DETACHED. INSTEAD, THE DEVICE WAS PULLED BACK QUICKLY, AND THE PRIMARY WIND OF THE DEVICE ELONGATED OUT OF THE ANEURYSM AND PARTIALLY INTO THE IVC. HE DEPLOYED A WALL STENT TO TRAP THE PORTION OF THE COIL THAT WAS IN THE IVC TO THE WALL OF THE VESSEL. NO PATIENT HARM OCCURRED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539052 ↗
• MalfunctionAug 29, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE COIL UNRAVELED DURING PROCEDURE. THE COIL WAS REMOVED WITH NO ISSUE AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929470 ↗
• MalfunctionAug 6, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A TIPS EMBOLIZATION OF GASTRIC VARICES, THE DOCTOR WENT TO DELIVER A COIL WHICH PREMATURELY DETACHED INSIDE THE CATHETER. SALINE WAS THEN FLUSHED INTO THE CATHETER, AND THE ENTIRE COIL WAS ABLE TO BE PUSHED OUT OF THE CATHETER, AND IT WAS DELIVERED INTO THE DESIRED VARICES. THE COIL LANDED IN THE INTENDED LOCATION. THERE WERE NO COMPLICATIONS REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734463 ↗
• MalfunctionApr 24, 2025Premature Separation; Premature Separation

  AS REPORTED, WHILE EMBOLIZING A SPLENIC ANEURYSM THROUGH A 4F CATHETER, THE SECOND COIL PLACED EXPERIENCED SOME RESISTANCE. FORWARD PRESSURE WAS PLACED ON THE COIL. WHEN THE PHYSICIAN DECIDED TO REPOSITION THE CATHETER, THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL. UNFORTUNATELY, THE COIL HAD DETACHED WITHIN THE CATHETER. THE CATHETER WAS REMOVED AND THE COIL ALONG WITH IT. THE CATHETER WAS THEN REINSERTED/REPOSITIONED AND 7 ADDITIONAL COILS WERE SUCCESSFULLY PLACED. THERE WAS NO PATIENT INJURY NOR SURGICAL INTERVENTION. THERE WERE NO ISSUES WITH THE PATIENT AND THE CASE WAS A SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902852 ↗
• MalfunctionMar 24, 2025Premature Separation; Premature Separation

  AS REPORTED: TRIED TO PLACE THE COIL IN A LARGE RENAL ARTERY WHILE THERE WAS A AMPLATZER PLUG IN THE VESSEL. THE PHYSICIAN WAS MANIPULATING THE COIL TRYING TO GET IT SET IN THE RIGHT PLACE SO IT WOULD NOT MIGRATE. THE COIL DETATCHED WHILE HE WAS TRYING TO MANIPULATE IT IN THE VESSEL. HE DID NOT FEEL COMFORTABLE JUST PUSHING IT OUT AS IT WAS A HIGH FLOW VESSEL. HE CAREFULLY WAS ABLE TO PULL THE SYSTEM OUT WITH THE COIL IN THE BASE CATHETER. THE CASE WAS COMPLETED, WITH AN AMPLATZER PLUG AND ONE .035 COIL. PATIENTS STATUS IS FINE, PROCEDURE WAS A SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679772 ↗
• MalfunctionJan 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PELVIC CONGESTION EMBOLIZATION, A 16X32 COIL WAS INSERTED IN STANDARD FASHION INTO A CATHETER WHILE OBSERVING UNDER X-RAY GUIDANCE IT WAS NOTED THAT THE COIL COULD NOT BE SEEN EXITING THE CATHETER EVEN THOUGH ENOUGH PUSHER WIRE WAS INSERTED. AFTER REMOVING THE PUSHER WIRE BY RE-SHEATHING IT, THE ENTIRE CATHETER WAS X-RAYED LOOKING FOR A DETACHED COIL. NO COIL WAS SEEN IN THE CATHETER. ADVANCING THE PUSHER WIRE OUT OF ITS SHEATHING IT WAS NOTED THAT NO COIL WAS ON PUSHER WIRE. A NEW 16 COIL WAS OPENED AND DEPLOYED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124689 ↗
• MalfunctionMar 20, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE AZUR COIL WAS USED IN AN ENDOLEAK EMBOLIZATION PROCEDURE. DURING IMPLANTATION, IT APPEARED THAT THERE WAS NO COIL ATTACHED TO THE PUSHER WIRE. THE PUSHER WAS REMOVED AND THE MISSING COIL WAS VERIFIED. UPON FURTHER INSPECTION, THE COIL WAS LOCATED SEVERED FROM THE PUSHER SYSTEM INSIDE THE ORIGINAL DISPENSER HOOP THAT IT IS PACKAGED IN. A DIFFERENT COIL WAS USED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946254 ↗
• MalfunctionJan 12, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT A EMBOLIZATION COIL IMPLANT WAS BEING POSITIONED AND WAS HALFWAY OUT OF THE CATHETER WHEN IT WAS ATTEMPTED TO BE RETRACTED FOR REPOSITIONING. THE IMPLANT DETACHED UNEXPECTEDLY. THE PHYSICIAN ATTEMPTED TO FLUSH THE IMPLANT OUT AND THEN ATTEMPTED TO PUSH IT OUT WITH MULTIPLE GUIDEWIRES BUT WAS UNSUCCESSFUL. THE IMPLANT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO EFFECT TO THE PATIENT. THERE WAS NO INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506500 ↗
• MalfunctionFeb 14, 2023Premature Separation; Premature Separation

  SEE H10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376005 ↗
• MalfunctionFeb 10, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THE PHYSICIAN WAS USING GLIDE CATHETER FROM ANOTHER MANUFACTURER TO DELIVER A COIL DURING A TYPE II ENDO LEAK CASE. UPON DELIVERING A COIL THE DOCTOR NOTICED THAT THE COIL WAS STUCK AND UNABLE TO ADVANCE OR WITHDRAW FROM THE GLIDE CATHETER. ADDITIONAL EFFORT WAS MADE, AND THE COIL BECAME DETACHED FROM THE COIL WIRE WHILE MOST OF THE COIL WAS ADVANCED INTO THE PATIENT. UPON FURTHER MANIPULATION TO TRY AND DELIVER THE COIL AND WITHDRAW THE CATHETER THE TIP OF THE GLIDE CATHETER SEPARATED WHILE THE BACK PORTION CAME OUT. THE ENTIRE COIL WAS IMPLANTED IN THE PATIENT. THE CASE WAS ABLE TO BE COMPLETED WITH THE USE OF A DIFFERENT CATHETER. THE PATIENT WAS STABLE, AND CASE WAS COMPLETED; HOWEVER, A PORTION OF THE GLIDE CATHETER WAS LEFT IN PATIENT. THE GLIDE CATHETER IS NOT A MICROVENTION MANUFACTURED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353035 ↗
• InjuryAug 26, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A RIGHT PULMONARY ARTERY PSEUDOANEURYSM, WITH ACCESS FROM THE NECK, THE COIL WAS DEPLOYED; HOWEVER, PHYSICIAN WAS UNSURE IF IT WOULD FIT IN THE DESIRED AREA. AN ATTEMPT WAS MADE TO BACK THE COIL OUT; HOWEVER, THE PUSHER WIRE BROKE, AND THE PHYSICIAN WAS ABLE TO SNARE THE LOOSE PROXIMAL PORTION OF THE COIL AND REMOVE IT IN ITS ENTIRETY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306485 ↗
• MalfunctionAug 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE COIL AND CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242035 ↗
• InjuryAug 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT TIPS, THE PHYSICIAN WAS COILING VARICES. THE REPORTED COIL WAS PUSHED OUT, AND THE PHYSICIAN DECIDED HE WANTED TO HAVE IT GO IN ANOTHER DIRECTION. DURING AN ATTEMPT TO PULL THE COIL BACK IN THE CATHETER, THE COIL WOULD NOT GO AND UNABLE TO BE RE-SHEATHED. AS A RESULT, THE PHYSICIAN TOOK THE CATHETER OUT AND PUT A SNARE IN TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY, AND THE PATIENT WAS REPORTED TO BE DOING GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15186687 ↗
• MalfunctionMay 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE FOR THE GASTRIC ARTERY, THE IMPLANT COIL DETACHED UNEXPECTEDLY AFTER REPOSITIONING. THE COIL WAS PLACED ENTIRELY WITHIN THE INTENDED TREATMENT SITE WITH THE DELIVERY PUSHER. THE CASE WAS CONTINUED WITHOUT ISSUES. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT'S CONDITION WAS REPORTED TO BE "NO HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366352 ↗
• MalfunctionDec 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN OVARIAN VEIN EMBOLIZATION AND WHEN AN EMBOLIZATION COIL IMPLANT WAS BEING REMOVED FROM ITS PACKAGING, IT WAS NOTICED THAT THE DELIVERY PUSHER WAS ALREADY KINKED. THE PUSHER WAS STRAIGHTENED AND USED. THE IMPLANT DETACHED FROM THE DELIVERY PUSHER IN THE MICROCATHETER. THERE WAS NO REPORTED PATEINT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929990 ↗
• InjuryDec 17, 2020Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM, THE EMBOLIZATION COIL DETACHED IN THE CATHETER DURING RETRACTION AND STRETCHED IN THE ARTERY DURING REMOVAL OF THE CATHETER. A COVERED STENT WAS IMPLANTED TO SECURE THE COIL TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY OR SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11031612 ↗
• MalfunctionAug 5, 2020Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL WAS DIFFICULT TO ADVANCE INTO THE COIL PACK DURING A CARTO PROCEDURE. AFTER REMOVAL OF THE PUSHER FROM THE PATIENT, THE COIL WAS NOTED TO BE DETACHED FROM THE PUSHER WIRE. THE CATHETER WAS REMOVED TOGETHER WITH THE DETACHED COIL SEGMENT AND REPLACED TO COMPLETE THE PROCEDURE. NO PORTION OF THE COIL REMAINS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366009 ↗
• MalfunctionJun 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL DETACHED UNEXPECTEDLY INSIDE THE CATHETER AFTER ONLY A SMALL PORTION OF THE COIL HAD EXITED THE CATHETER. THE COIL WAS WITHDRAWN FROM THE PATIENT TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201378 ↗
• MalfunctionNov 28, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AN EMBOLIZATION COIL BECAME DETACHED INSIDE OF A CORDIS BRAND CATHETER. THE EMBOLIZATION COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9389499 ↗
• MalfunctionMay 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A RIGHT INTERNAL ILIAC ANEURYSM, THE COIL COULD NOT ADVANCE MORE THAN 5CM INTO THE ANEURYSM. WHEN THE COIL WAS WITHDRAWN, THE PUSHER WAS FOUND TO BE DETACHED. IT WAS ATTEMPTED TO PUSH THE COIL INTO THE ANEURYSM WITH THE PUSHER WIRE, BUT IT WOULD NOT ADVANCE. THE ENTIRE COIL WAS REMOVED WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656774 ↗
• MalfunctionFeb 22, 2019Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A PROXIMAL SPLENIC ARTERY FOR A PREOPERATIVE EMBOLIZATION OF THE SPLENIC ARTERY, AN AZUR COIL IN A HIGH FLOW ARTERY WAS USED. THE COIL WOULD NOT SET UP PROPERLY IN THE VESSEL AND KEPT MOVING DISTALLY. THE COIL WAS RETRACTED AND RE-DEPLOYED SEVERAL TIMES RESULTING IN THE COIL DETACHING FROM THE DELIVERY PUSHER. IT WAS REPORTED THAT THE PHYSICIAN INDICATED THAT HE TWISTED (TORQUED) THE DELIVERY PUSHER WHILE TRYING TO GET THE COIL TO SEAT PROPERLY, AND INDICATED THAT THE TECHNIQUE MAY HAVE COMPROMISED THE INTEGRITY OF THE COIL/PUSHER WIRE CONNECTION. THE COIL COULD NOT BE REMOVED. NO ATTEMPTS WERE MADE TO RETRIEVE THE COIL. IT WAS A PREOPERATIVE EMBOLIZATION TO SLOW DOWN BLOOD FLOW PRIOR TO THE PATIENTS SPLENECTOMY. THE SPLEEN IS BEING REMOVED SO HAVING A COIL IN THE ARTERY BLOCKING FLOW ACTUALLY HELPS EVEN THOUGH THE PHYSICIAN WOULD'VE LIKED IT TO BE MORE PROXIMAL. THE COIL REMAINS IN THE MID SPLENIC ARTERY. THE SPLEEN WAS GOING TO BE REMOVED AND THEN THE ARTERY WOULD BE LIGATED. THE COIL IS NOT IMPENDING FLOW. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED WITH THIS EVENT. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363894 ↗
• InjuryDec 26, 2018Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A HYPOGASTRIC ARTERY, THE COIL DID NOT DETACH WITH THE CONTROLLER. 2-3 ADDITIONAL ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE CONTROLLER; HOWEVER, THE COIL DID NOT DETACH. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AS A SINGLE UNIT FROM THE DESTINATION SHEATH. UPON INSPECTION OF THE DEVICES AFTER REMOVAL, IT WAS NOTED THAT A PIECE OF THE COIL REMAINED INSIDE THE SHEATH. THE DETACHED COIL SEGMENT WAS PUSHED OUT OF THE SHEATH INTO THE HYPOGASTRIC ARTERY AND COVERED WITH A GORE LIMB EXTENSION ENDOPROSTHESIS. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196811 ↗
• MalfunctionOct 5, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION IN THE RIGHT INTERNAL ILIAC ARTERY, RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL IN THE CATHETER. DURING THE REMOVAL ATTEMPT, THE COIL DETACHED IN THE CATHETER. AN ATTEMPT WAS MADE TO PUSH THE COIL OUT WITH THE GLIDEWIRE; HOWEVER, IT WAS UNSUCCESSFUL. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940150 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE EMBOLIZATION TREATMENT FOR A SPLENIC ARTERY ANEURYSM, THE COIL WAS NOT FORMING TO THE SATISFACTION OF THE PHYSICIAN. DURING RETRACTION OF THE COIL TO REPOSITION IT, THE IMPLANT COIL DETACHED IN THE CATHETER, WITH 1/2 OF THE COIL IN THE CATHETER AND 1/2 OF THE COIL IN THE ARTERY. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY TOGETHER WITH THE CATHETER FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866827 ↗