Azur CX Detachable 45-780413Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00810170018299), received between Mar 15, 2017 and Nov 14, 2025 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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.

• MalfunctionNov 14, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WOULD NOT DEPLOY. THE COIL WAS POSITIONED BUT THE PHYSICIAN DECIDED TO REMOVE AND RESHEATH IT TO REPOSITION HIS MICROCATHETER. UPON REMOVAL THE PHYSICIAN NOTED THAT THE COIL HAD DETACHED. THE COIL WAS CLOSE TO WHERE THE PHYSICIAN WANTED IT TO BE, JUST NOT PACKED APPROPRIATELY. THERE WAS NO NEGATIVE IMPACT FROM THE COIL DETACHING EARLY AND BEFORE THE PHYSICIAN WANTED IT. THE PROCEDURE WAS SUCCESSFUL, NOT PROLONGED, AND THE PATIENT HAD AN UNEVENTFUL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559783 ↗
• MalfunctionAug 13, 2025Premature Separation; Premature Separation

  AS REPORTED, PLUG NOT RELEASING PROPERLY. REMOVAL IMPOSSIBLE. REMOVAL VIA CATHETER AND ANALYSIS OF PLUG, PLUG CUT IN HALF. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800559 ↗
• MalfunctionMar 7, 2025Premature Separation; Premature Separation

  ADDITIONAL INFORMATION RECEIVED NOTES THE PROCEDURE WAS COMPLETED BY USING PENUMBRA COILS WITH NO FURTHER INCIDENTS. NO OTHER CLARIFICATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21550281 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED IN AN INTERVENTIONAL RADIOLOGY AN AZUR COIL WAS USED DURING THE PROCEDURE. THE DEVICE RELEASE WIRE BROKE DURING USE, PREVENTING USE OF THE EQUIPMENT WITH THE RELEASE HANDLE. NO CLINICAL CONSEQUENCES REPORTED FOR THE PATIENT. THE COIL WAS REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INCIDENT INFORMATION WERE MADE, HOWEVER, NOT YET RECEIVED AT THE TIME OF THIS REPORT. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300894 ↗
• MalfunctionJan 24, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL IMPLANT WAS USED IN A SPLENIC ARTERY EMBOLIZATION PROCEDURE. WHEN THE COIL WAS PUT THROUGH THE MICROCATHETER IT WOULD NOT FORM AND UPON REMOVAL ATTEMPT, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE CATHETER ALONG WITH COIL WERE REMOVED FROM THE PATIENT, AND A NEW CATHETER AND COILS WERE USED TO SUCCESSFULLY COMPLETED THE CASE. NO REPORT OF HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231507 ↗
• MalfunctionSep 26, 2024Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DID NOT DETACH WITH A DETACHMENT CONTROLLER WHEN IT WAS IN SITU. A TORQUE DEVICE WAS THEN USED TO DETACH THE COIL; HOWEVER, THE COIL STRETCHED, WITH HALF REMAINING IN THE COIL PACK AND HALF IN THE MICROCATHETER. MULTIPLE EFFORTS WERE MADE TO FLUSH THE COIL OUT OF THE CATHETER AND A WIRE WAS EVENTUALLY USED TO PUSH THE COIL OUT OF THE MICROCATHETER. THE COIL WAS IMPLANTED. THERE WAS NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311331 ↗
• MalfunctionSep 17, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS THE FIFTH COIL TO BE DEPLOYED IN THE PATIENT. THE COIL DID NOT DETACH SO IT WAS REMOVED. TWO ADDITIONAL COILS WERE IMPLANTED AFTER THIS COIL. THERE WAS NO INJURY OR INTERVENTION. ONCE RECEIVED, THE INVESTIGATION OF THE RETURNED DEVICE SHOWED THAT THE DEVICE HAD PULLED OUT A PREVIOUSLY PLACED COIL WHEN IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243266 ↗
• MalfunctionAug 7, 2024Premature Separation; Premature Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED, PLEASE SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934798 ↗
• MalfunctionJan 9, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED FROM THE DELIVERY PUSHER UNEXPECTEDLY. THE COIL WAS IN THE PROPER POSITION AND SO WAS LEFT IN PLACE. THERE WAS NO PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16123312 ↗
• MalfunctionJul 13, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED AND STRETCHED 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 15009634 ↗
• MalfunctionJun 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION TREATMENT, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE ENTIRE COIL AND CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THE DEVICE WAS DISCARDED. THERE WAS NO REPORTED INJURY OR INTERVENTION. THE PATIENT IS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577903 ↗
• MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LUMBAR ARTERY COILING PRE-ENDOGRAFT PLACEMENT PROCEDURE, THE EMBOLIZATION COIL WAS BEING INTRODUCED FROM COIL SHEATH INTO THE MICROCATHETER WHEN IT BECAME HARD TO PUSH. THE PHYSICIAN ESTIMATED THAT THE COIL AND PUSHER WIRE ONLY MADE IT IN APPROXIMATELY 20CM. UPON WITHDRAWAL OF THE COIL, IT WAS NOTED THAT THE COIL WAS NO LONGER STILL ATTACHED TO THE PUSHER WIRE. PHYSICIAN THEN ATTEMPTED TO PUSH THE COIL USING THE BACKEND OF A GUIDE WIRE (NOT A MVI PRODUCT) AND FLUSH THE COIL USING NORMAL SALINE, BUT UNSUCCESSFULLY. WHEN THE GUIDE WIRE WAS RETRACTED, THE COIL SNAGGED THE WIRE AND WAS ABLE TO BE RETRIEVED FROM THE CATHETER HUB. SUBSEQUENT COILS WERE USED AND DEPLOYED SUCCESSFULLY USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982775 ↗
• MalfunctionMar 17, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS NOTICED TO BE DETACHED FROM THE DELIVERY PUSHER WITHIN THE MICROCATHETER. THE DEVICE WAS REMOVED WITH THE MICROCATHETER IN ITS ENTIRETY. THERE WAS NO REPORTED INTERVENTION OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792192 ↗
• MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE COIL UNINTENTIONALLY DETACHED FROM THE DELIVERY PUSHER DURING ADVANCEMENT. REPORTEDLY, THE COIL WAS PLACED SUCCESSFULLY AT THE INTENDED TREATMENT SITE. THERE WAS NO PATIENT INJURY OR SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625632 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED FROM THE PUSHER WHEN ATTEMPTED TO DEPLOY OUT OF THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED TDO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180821 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BRONCHIAL ARTERY EMBOLIZATION, AN EMBOLIZATION COIL DETACHED IN THE MICROCATHETER DURING REPOSITIONING. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER WITHOUT INCIDENT FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510390 ↗
• MalfunctionAug 21, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ADVANCEMENT OF AN EMBOLIZATION COIL, A LOT OF RESISTANCE WAS ENCOUNTERED AND THE COIL DETACHED IN THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10439875 ↗
• MalfunctionJul 24, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS DIFFICULT TO ADVANCE THROUGH THE MICROCATHETER. DURING THE ATTEMPT TO REMOVE THE COIL, THE COIL DETACHED FROM THE PUSHER WIRE IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320542 ↗
• MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TYPE II ENDOLEAK REPAIR, AN EMBOLIZATION COIL IMPLANT WAS ADVANCED TO THE L4 LUMBAR ARTERY, BUT DID NOT COIL CORRECTLY. IT WAS DECIDED THAT THE COIL WAS NOT THE CORRECT SIZE FOR THE TARGET, AND IT WAS WITHDRAWN. UPON ATTEMPTED WITHDRAWAL, IT WAS NOTICED THAT THE IMPLANT COIL HAD BECOME DETACHED FROM THE DELIVERY PUSHER. THE IMPLANT WAS PUSHED INTO POSITION WITH THE DELIVERY PUSHER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226256 ↗
• MalfunctionAug 29, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ADVANCEMENT WITHIN A CATHETER, AN EMBOLIZATION IMPLANT COIL DETACHED. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947762 ↗
• InjuryApr 3, 2019Difficult to Remove; Detachment of Device or Device Component; Migration; Difficult to Remove; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS ATTEMPTED ON THE GASTRODUODENAL ARTERY (GDA) TO PREPARE FOR Y90 TREATMENT USING THE LEFT HEPATIC ARTERY. WHILE ADVANCING THE COIL THROUGH THE CATHETER, THE CATHETER POPPED OUT OF THE GDA AND INTO THE RIGHT HEPATIC ARTERY. THE COIL WAS REMOVED PRIOR TO AN ATTEMPT TO REPOSITION THE CATHETER, AND THE CATHETER WAS FLUSHED UNDER FLUOROSCOPY, AT WHICH TIME THE IMPLANT COIL COULD BE SEEN EXITING OUT OF THE CATHETER INTO THE PROPER RIGHT HEPATIC ARTERY. DURING AN ATTEMPT TO REMOVE THE COIL WITH A GOOSENECK SNARE, THE COIL MOVED FURTHER DOWNSTREAM AND OCCLUDED A BRANCH OF THE RIGHT HEPATIC ARTERY. SEVERAL MORE ATTEMPTS WERE MADE TO RETRIEVE THE COIL; HOWEVER, THEY WERE UNSUCCESSFUL AND THE PROCEDURE WAS FINISHED. THE PHYSICIAN COMMENTED THAT THE OCCLUDED VESSEL WILL NOT HAVE AN IMMEDIATE IMPACT ON THE PATIENT'S TREATMENT PLAN, AS THE MOST SIGNIFICANT DISEASE IS IN THE LEFT LOBE. THE PATIENT HAS METASTATIC DISEASE THROUGHOUT THE LIVER, HOWEVER, AND THE AREA OF THE LIVER WHICH WAS FED BY THE ARTERY IN WHICH THE COIL SETTLED HAS A SIGNIFICANT TUMOR. THE TUMOR WILL FIND BLOOD SUPPLY FROM OTHER COLLATERAL BRANCHES AND THOSE WILL REVASCULARIZE THE AREA.

  Patient problems: Occlusion

  MAUDE report 8479293 ↗
• MalfunctionFeb 14, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER INSERTION INTO THE CATHETER, THE COIL WOULD NOT ADVANCE. UPON REMOVAL, THE COIL APPEARED TO HAVE SEPARATED FROM THE PUSHER WIRE. 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 8341852 ↗
• MalfunctionJan 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF THE COIL AT THE TREATMENT SITE, THE COIL DETACHED INSIDE THE CATHETER. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY TOGETHER WITH THE CATHETER. 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 8220376 ↗
• MalfunctionDec 21, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED ADVANCING THE COIL THROUGH THE MICROCATHETER. DURING REMOVAL, THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191851 ↗
• MalfunctionJul 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL IN THE MICROCATHETER, AND THE COIL DETACHED. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737707 ↗