Azur CX Detachable 45-750812Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00812636021058), received between Apr 2, 2017 and Apr 30, 2026 — classified as 9 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Premature Separation

  AS REPORTED: DURING SPLENIC EMBOLIZATION, THE COIL DEPLOYED UPON ITSELF. THE COIL STRETCHED AND STRUNG OUT ON ITS OWN OUTSIDE OF THE CATHETER AND WAS DANGLING FREELY IN THE BODY WHERE IT SHOULD NOT HAVE BEEN. THE STAFF HAD TO SNARE IT OUT OF THE BODY TO ELIMINATE THE CHANCES OF THE DEFECTIVE COIL FROM MIGRATING ELSEWHERE. THE SAME SIZE COIL WAS USED AND DEPLOYED WITH NO ISSUES PRIOR TO THIS COIL MALFUNCTIONING. FOR CASE COMPLETION, THE STAFF WAS ABLE TO EMBOLIZE THE VESSEL BEING TREATED AND THE PATIENT WAS OK POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049821 ↗
• InjuryJun 4, 2025Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PROCEDURE ON THE LEFT INTERNAL ILIAC EMBOLIZATION WITH COMMON ILIAC LIMB STENT PLACEMENT (TO COVER THE EMBOLIZED INTERNAL ILIAC), 17 COILS IMPLANTED SUCCESSFULLY VIA A 4FR CATHETER & 150CM MICROCATHETER. PHYSICIAN LEFT 4FR CATHETER IN THE INTERNAL ILIAC AND DEPLOYED THE COMMON ILIAC LIMB (JAILING THE CATHETER TO PLACE ONE FINAL COIL). AN 8X12 COIL WAS DELIVERED AND PLACED DETACHMENT CONTROLLER WAS USED TO DETACH (LIGHT WAS GREEN & 3 AUDIBLE BEEPS CONFIRMING THE DETACHMENT). PHYSICIAN ATTEMPTED TO REMOVE PUSHER WIRE AND REALIZED IT WAS SOMEHOW STILL ATTACHED THE COIL MOVED SLIGHTLY AND THEN THE PUSHER WIRE CAME FREE AND WAS REMOVED UNDER FLUOROSCOPY THE TEAM NOTICED THERE WAS A SMALL ALMOST INVISIBLE COIL LIKE WIRE DANGLING (STILL ATTACHED) TO THE PROXIMAL END OF THE COIL (APPEARED TO BE THE MONO-FILAMENT USED TO TRANSMIT THE SIGNAL TO DETACH THE COIL). THE PROXIMAL END OF THE FILAMENT WAS HANGING OVER THE ILIAC BIFURCATION INTO THE CONTRALATERAL COMMON ILIAC. PHYSICIAN ATTEMPTED TO SNARE SEVERAL TIMES BUT WAS UNSUCCESSFUL. ULTIMATELY THE PHYSICIAN FELT THE BEST COURSE OF ACTION WAS TO DO NO MORE AND FINISH THE PROCEDURE. NO INJURY REPORTED TO THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147038 ↗
• InjuryMar 6, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  IT WAS REPORTED THAT WHILE TREATING A WATCHMAN LEAK, A EMBOLIZATION COIL IMPLANT WAS SELECTED AS THE 7TH COIL FOR TREATMENT. THE COIL WOULD NOT FIT IN THE COIL PACK SO THE PHYSICIAN PULLED THE COIL BACK, BUT THE COIL DISCONNECTED FROM THE PUSHER WIRE AND THE PUSHER WIRE UNRAVELED IN THE CATHETER. THE PHYSICIAN USES A BALLOON TO TRAP THE COIL AGAINST THE CATHETER AND PULL IT OUT. THE COIL PACK WAS SUFFICIENT AND THEY WERE SATISFIED WITH THE OUTCOME. THEY DID NOT NEED TO PLACE ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542819 ↗
• MalfunctionApr 12, 2024Premature Separation; Premature Separation

  AS REPORTED, DURING A PELVIC EMBOLIZATION 035 CATHETER WAS IN PLACE, COIL WAS ADVANCED OUTSIDE OF CATHETER DURING THE END OF COIL PLACEMENT. THE PHYSICIAN WAS MANIPULATING THE POSTERIOR END OF THE COIL PULLING IN AND OUT OF THE CATHETER MULTIPLE TIMES AT ONE POINT THE COIL WOULDN'T MOVE IN CORRELATION TO THE PUSHER WIRE. THE COIL WAS THEN ATTEMPTED TO DETACH. WHEN THE PUSHER COIL WAS RETRACTED TO COIL WAS STUCK WITHIN THE CATHETER. THE CATHETER WAS THEN PULLED BACK INTO THE SHEATH AND BACK OUT OF THE PATIENT. ADDITIONAL INFORMATION INDICATED, THE COIL BECAME DISLODGED FROM THE PUSHER WIRE. DETACHMENT ATTEMPT FAILED. THE ENTIRE SYSTEM WAS THEN RETRACTED BACK IN TO THE CATHETER AND PULLED OUT. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102212 ↗
• MalfunctionJan 31, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSCIAN WAS EMBOLIZING A GASTRIC VARICE THROUGH A COMPETITORS BALLOON CATHETER. THE PHYSICIAN DEPLOYED SEVERAL COILS WITH NO INCIDENT. THE PHYSICIAN THEN TRIED TO REPOSITION THE EVENT COIL. SUBSEQUENTLY, THE COIL BEGAN TO UNRAVEL AND DETACHED WITHIN THE CATHETER. THE BALLOON CATHETER AND COIL WERE THEN REMOVED TOGETHER. THERE WAS NO EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619699 ↗
• MalfunctionJun 2, 2023Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED IN CONJUNCTION WITH AN EVAR PROCEDURE. INTERNAL ILIAC BRANCH MEASURED AROUND 9CM DISTALLY WITH INCREASING DIAMETER PROXIMALLY. REPORTEDLY, THE COIL EXPERIENCED EXTREME RESISTANCE IN THE 4FR 65CM ANGLED MICROCATHETER FROM ANOTHER MANUFACTURER AND COULD NOT BE ADVANCED. THE MICROCATHETER WAS EXCHANGED FOR A 5FR 100CM ANGLED CATHETER WITH NO REAL IMPROVEMENT. THE COIL UNRAVELED AND UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED WITH THE CATHETER. USE OF COILS WAS ABORTED WITH ONLY ONE COIL PLACED AND THE PHYSICIAN DECIDED TO CONTINUE WITHOUT FULL EMBOLIZATION. ONLY 1 OF 5 COILS WERE DEPLOYED SUCCESSFULLY. ANATOMY WAS NORMAL WITH NO TORTUOSITY. NO REPORT OF HARM OR INJURY TO THE PATIENT AND DESCRIBED AS "NORMAL." THIS IS REPORT 4 OF 4 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054596 ↗
• InjuryApr 28, 2023Stretched; Premature Separation; Stretched; Premature Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16840332 ↗
• MalfunctionJan 10, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY DURING REPOSITIONING. THE CATHETER WAS REMOVED WITH THE COIL INSIDE OF IT. THERE WAS NO INTERVENTION OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131821 ↗
• MalfunctionDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE SECTION H:10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965268 ↗
• InjuryApr 18, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE FOR A VARICOCELE, THE COIL IMPLANT WAS NOTICED TO BE MISSING FROM THE DELIVERY SYSTEM WHEN IT WAS IN THE VESSEL. THE DELIVERY SYSTEM WAS REMOVED. A SECOND COIL WAS SELECTED WHEN IT WAS OBSERVED THAT THE VESSEL WAS BLEEDING. THE SECOND COIL WAS APPARENTLY IMPLANTED, THE PROCEDURE WAS STOPPED, AND THE PATIENT HAS A REMAINING VARICOCELE. IT WAS REPORTED THAT IT WAS NOT KNOWN IF THE BLEED HAD OCCURRED DUE TO THE STATED MALFUNCTION. THE ANATOMY WAS STATED TO BE "NOT EASY." AN ADDITIONAL PROCEDURE IS BEING CONSIDERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11683272 ↗
• InjuryDec 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL DETACHED IN THE WRONG LOCATION AND PROTRUDES INTO THE PATIENT'S AORTA. THERE WAS NO REPORTED INTERVENTION.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 9507667 ↗
• InjuryOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL IMPLANT DETACHED PREMATURELY. A SNARE WAS USED TO RETRIEVE THE DETACHED COIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227094 ↗
• MalfunctionAug 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ADVANCEMENT OF AN EMBOLIZATION COIL IN THE CATHETER, THE IMPLANT DETACHED HALFWAY TO THE TREATMENT SITE. THE COIL WAS THEN PUSHED INTO THE TREATMENT SITE AND PLACED WITHOUT ANY REPORTED ISSUES. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8918977 ↗
• InjuryDec 26, 2018Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Remove; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF A COIL IN AN ANASTOMOSIS TO A VEIN GRAFT, THE COIL GOT CAUGHT IN A BRANCH AND STRETCHED. DURING AN ATTEMPT TO REMOVE THE COIL, THE STRETCHED COIL BROKE. MULTIPLE ATTEMPTS WERE MADE WITH A SNARE DEVICE TO RETRIEVE THE COIL, BUT THEY WERE UNSUCCESSFUL. THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196617 ↗
• MalfunctionMay 23, 2018Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL DETACHED, AND WAS LEFT IMPLANTED IN THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537775 ↗
• MalfunctionNov 17, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING THE REPOSITIONING OF THE 2ND COIL FOR AN INTERNAL ILIAC EMBOLIZATION, THE PUSHER BROKE AND WAS NO LONGER CONNECTED TO THE COIL. BOTH SEGMENTS OF THE COIL WERE REMOVED ALONG WITH THE MICROCATHETER FROM THE PATIENT. 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 7043183 ↗
• MalfunctionAug 5, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT 11 COILS WERE IMPLANTED FOR TREATMENT OF A TYPE II ENDOLEAK. A LIQUID EMBOLIC WAS USED PRIOR TO IMPLANTING THE 12TH COIL. DURING POSITIONING OF THE 13TH COIL, THE CATHETER "LOST POSITION" AND THE COIL NO LONGER APPEARED TO BE CONNECTED TO THE PUSHER WIRE. PART OF THE COIL HAD BEEN PARTLY DELIVERED IN THE ANEURYSM AND PART OF IT WAS STUCK IN THE CATHETER. THE ENTIRE COIL AND PUSHER WERE REMOVED TOGETHER WITH THE CATHETER AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769706 ↗
• InjuryApr 2, 2017Detachment Of Device Component; Difficult to Remove; Stretched; Detachment Of Device Component; Difficult to Remove; Stretched

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PULL THE AZUR COIL BACK, IT WAS NOTED THAT THE COIL HAD BECOME DETACHED IN THE CATHETER. THE COIL WAS PUSHED WITH A 3CC SYRINGE WITH SALINE. AT THAT TIME IT WAS NOTED THAT PART OF THE COIL WIRE WAS STILL ATTACHED TO THE COIL. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL WITH A SNARE DEVICE, BUT IT WAS UNSUCCESSFUL AND THE COIL WAS LEFT BEHIND. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6452437 ↗