Azur CX Detachable 45-751019Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00812636021072), received between Jun 27, 2017 and May 7, 2026 — classified as 14 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119649 ↗
• InjuryApr 6, 2026Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO SEAL A RESIDUAL LEAK FOLLOWING A WATCHMAN PROCEDURE IN THE LEFT ATRIAL APPENDAGE. THE COIL WAS ADVANCED THROUGH A 6F CORONARY GUIDE CATHETER; HOWEVER, THE LUMEN OF THE CATHETER WAS BELIEVED TO BE TOO LARGE. THE COIL SUBSEQUENTLY DETACHED PREMATURELY WITHIN THE 6F GUIDE CATHETER AND DID NOT EXIT THE TIP OF THE CATHETER, BECOMING LODGED WITHIN THE SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE AND RETRIEVE THE COIL WITHOUT ANY HARM TO THE PATIENT. AN AMPLATZER PLUG WAS THEN USED TO TREAT THE LEAK BEHIND THE WATCHMAN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787196 ↗
• InjuryMar 9, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL WOULD NOT DEPLOY AND WHEN IT WAS TAKING IT OUT IT GOT STUCK IN THE CATHETER. THE PHYSICIAN WAS ABLE TO FORCE IT OUT WITH A WIRE AND THEN CONTRAST. HE PULLED ANOTHER 035 COIL AND THE SAME THING HAPPENED. SINCE HE WAS ABLE TO DEPLOY BOTH, THE CASE WAS ABLE TO BE FINISHED SUCCESSFULLY. UNSURE IF THEY WERE FLUSHING BETWEEN EACH DEPLOYMENT. ADDITIONAL INFORMATION: THEY WERE DEPLOYED IN THE BODY, AND THEY BECAME DETACHED IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553871 ↗
• InjuryFeb 20, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL WOULD NOT DEPLOY AND WHEN IT WAS TAKING IT OUT IT GOT STUCK IN THE CATHETER. THE PHYSICIAN WAS ABLE TO FORCE IT OUT WITH A WIRE AND THEN CONTRAST. HE PULLED ANOTHER 035 COIL AND THE SAME THING HAPPENED. SINCE HE WAS ABLE TO DEPLOY BOTH, THE CASE WAS ABLE TO BE FINISHED SUCCESSFULLY. UNSURE IF THEY WERE FLUSHING BETWEEN EACH DEPLOYMENT. ADDITIONAL INFORMATION: THEY WERE DEPLOYED IN THE BODY, AND THEY BECAME DETACHED IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403738 ↗
• MalfunctionJan 30, 2026Component Missing

  IT WAS REPORTED THAT DURING A RIGHT HEPATIC VEIN AND PORTAL VEIN EMBOLIZATION PROCEDURE, THE PHYSICIAN HUBBED THE COIL CATHETER INTO THE 4FR GLIDECATH AND INSERTED THE COIL PUSHER WIRE INTO THE CATHETER. HE THEN NOTICED THAT THERE WAS NO COIL ATTACHED UNDER XRAY WHILE STILL INSIDE THE GLIDECATH. HE PULLED THE PUSHER WIRE OUT AND CONFIRMED THAT THERE WAS NO COIL ATTACHED TO THE PUSHER WIRE AND THERE WERE NO COILS INSIDE THE BODY. IT IS ASSUMED THE COIL WAS NEVER ATTACHED TO THE PUSHER WIRE, AND WAS NOT PRE-MATURELY DETACHED, THEREFORE NO COIL WAS EVER LOCATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PROCEEDING TO IMPLANT ADDITIONAL AZUR CX COILS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225010 ↗
• InjuryOct 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION OF A SPLENIC ANEURYSM, THE COIL DETACHED WITHIN THE DELIVERY CATCHER LEAVING THE PROXIMAL END OF THE COIL IN THE SPLENIC ARTERY. THEY WERE ABLE TO SNARE THIS COIL AND WAS EXPLANTED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS CONSIDERED SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330346 ↗
• MalfunctionSep 19, 2025Stretched; Material Deformation; Premature Separation; Stretched; Material Deformation; Premature Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103003 ↗
• MalfunctionSep 16, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS USED IN A PATIENT FOR GASTRIC VARIX EMBOLIZATION. DURING ADVANCEMENT IN THE MICROCATHETER, THE COIL UNINTENTIONALLY PREMATURELY DETACHED IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL FROM THE MICROCATHETER WITHOUT PROBLEM. ADDITIONAL 17 COILS WERE IMPLANTED AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065221 ↗
• MalfunctionAug 20, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING A SPLENIC ANEURYSM COILING, A 6F 4CM SHEATH WAS IN THE SPLENIC ARTERY AND A 5F 65CM CATHETER WAS INTO THE OUTFLOW VESSEL OF THE ANEURYSM SAC. THE 10MMX19CM 035 AZUR CX COIL WAS ADVANCING INTO THE VESSEL, ABOUT HALFWAY INTO THE OUTFLOW VESSEL, THE COIL WASN'T FORMING SO THEY WENT TO PULL THE COIL BACK AND IT DETACHED. THE DOCTOR USED SALINE TO PUSH THE COIL THE REST OF THE WAY OUT OF THE CATHETER. THEY WANTED TO TUCK THE REST OF THE COIL OUT OF THE CATHETER, BUT THE WIRE WOULD NOT ADVANCE INTO THE CATHETER. THE DOCTOR FELT RESISTANCE. THE PROXIMAL PART OF THE COIL WAS STUCK IN THE TIP OF THE CATHETER. THE DOCTOR REMOVED THE CATHETER AND COIL OUT OF THE PATIENT. ALL OF THE COIL WAS REMOVED. THE PROCEDURE CONTINUED WITH SUCCESSFUL EMBOLIZATION. THE COIL DETACHED FROM THE PUSHER WIRE INSIDE THE CATHETER. REGARDING THE STATEMENT THE ¿DOCTOR USED SALINE TO PUSH THE COIL THE REST OF THE WAY OUT OF THE CATHETER¿, ONLY PART OF THE COIL WAS PUSHED OUT WITH SALINE, THE DISTAL END WAS STILL IN THE PROXIMAL PART OF THE CATHETER. NO SNARE WAS USED TO RETRIEVE THE COIL. WHEN THE DOCTOR PULLED BACK THE CATHETER, ALL OF THE COIL WAS REMOVED WITH THE CATHETER, SOME OF THE COIL WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855148 ↗
• MalfunctionJul 23, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING PELVIC VENOUS EMBOLIZATION, LEFT SIDE IPSILATERAL APPROACH. MULTIPLE COILS HAD BEEN DEPLOYED. WHILE ADVANCING AN ADDITIONAL 10X19 COIL THROUGH COBRA 2 CATHETER THE COIL BECAME STUCK AND DEPLOYED INSIDE THE CATHETER. THE COIL WAS THEN REMOVED SAFELY ALONG WITH THE CATHETER THAT HOUSED THE COIL. THERE WAS NO HARM TO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581005 ↗
• InjuryMar 17, 2025Premature Separation; Premature Separation

  AS REPORTED: DR. INSERTED THE AZUR CX .035 INTO THE CATHETER FOR PLACEMENT ON A TIPS REVISION CASE. HE STATED THAT AS HE WAS ADVANCING THE COIL, IT DETACHED FROM THE SHAFT. HE REMOVED THE SHAFT, THEN INJECTED SALINE TO FORCE THE COIL OUT OF THE CATHETER. HE THEN USED A SNARE TO REMOVE THE COIL AND AS HE WAS DOING THIS IT UNRAVELED. HE REMOVED ALL PRODUCTS EXCEPT THE SHEATH AND STARTED OVER. HE THEN PLACED THE CATHETER AND DEPLOYED ANOTHER AZUR CX .035 WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621117 ↗
• MalfunctionFeb 4, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING EMBOLIZATION OF THE RIGHT HYPOGASTRIC ARTERY, AN EMBOLIZATION COIL IMPLANT BECAME UNRAVELED DURING PLACEMENT. THE COIL WAS PUSHED INTO POSITION WITH A GLIDEWIRE. THERE WAS NO PATIENT INJURY. THE PATIENT WAS REPORTED TO BE FINE. THIS OCCURRED DURING THE SAME PROCEDURE AS THE DEVICE REPORTED IN A SEPARATE MDR - 2032493-2025-00098.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309518 ↗
• InjuryDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870458 ↗
• MalfunctionMar 18, 2024Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL DETACHED DURING THE PROCEDURE, THEN RECOVERED WITH A LASSO. NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923934 ↗
• MalfunctionJan 26, 2024Unraveled Material; Migration; Premature Separation; Unraveled Material; Migration; Premature Separation

  IT WAS REPORTED THAT DURING A SPLENIC ARTERY COIL EMBOLIZATION. THE DEVICE WAS INSERTED, AND IT BECAME STUCK IN THE INJECTOR AND WAS IMPOSSIBLE TO RELEASE. IT WAS THEN NECESSARY TO FLUSH THE COIL, WHICH IS POSITIONED TOO FAR AWAY AND ENDS UP IN THE SPLEEN. NEW COILS HAVE BEEN USED AND THIS WAS AN ISOLATED INCIDENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592566 ↗
• MalfunctionDec 20, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING RETRACTION OF THE COIL THROUGH THE CATHETER THE COIL SPONTANEOUSLY DETACHED. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370277 ↗
• MalfunctionOct 2, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PRE-ENDOVASCULAR ANEURYSM REPAIR (EVAR) EMBOLIZATION OF THE HYPOGASTRIC ARTERY PROCEDURE, THE DEPLOYMENT END OF THE COIL BROKE OFF INTO THE CATHETER. THE COIL WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY WITHIN THE CATHETER WITH NO EXTRA INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858264 ↗
• InjurySep 26, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SURGEON WAS COILING THE LEFT HYPOGASTRIC ARTERY AND HAD BOTH RIGHT AND LEFT FEMORAL ACCESS BUT DID NOT HAVE GOOD SUPPORT FROM THE SHEATH AND CATHETER. AS THE SURGEON WAS DEPLOYING THE COIL, THE COIL DETACHED EARLY IN THE CATHETER BEFORE THEY CONNECTED TO THE CONTROLLER. THE SURGEON ATTEMPTED TO REMOVE COIL WITH A SNARE DEVICE; HOWEVER, WAS UNABLE TO RETRIEVE, AND PUSHED THE COIL IN PLACE WHERE IT REMAINS IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822116 ↗
• MalfunctionSep 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL BROKE OFF IN THE CATHETER BEFORE DEPLOYMENT. THE ENTIRE CATHETER AND COIL WERE REMOVED. THERE WAS NO HARM TO THE PATIENT AND WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741963 ↗
• MalfunctionJul 25, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS AN INTERNAL ILIAC EMBOLIZATION FROM IPSILATERAL ACCESS. A GLIDE CATHETER WAS INSERTED INTO OUTFLOW VESSEL WITHIN INTERNAL ILIAC ARTERY AND WAS PREPPED AND ADVANCED. AS COIL WAS ADVANCING INTO VESSEL IT WAS NOT COILING AS SURGEON LIKED, HE ATTEMPTED TO PULL BACK AND RE-ADVANCED, BUT IT STILL DID NOT PACK PROPERLY. IT WAS DECIDED THAT COIL MAY HAVE BEEN TOO LARGE FOR SPACE AND SHOULD BE REMOVED. HE NOTED THAT HE COULD NOT PULL BACK THE COIL AND THEN THE COIL DETACHED. A GLIDE WIRE WAS INSERTED INTO THE CATHETER TO TRY AND PUSH THE COIL BUT WAS NOT ABLE TO GO IN VERY FAR AS COIL HAD STRETCHED INSIDE CATHETER. CATHETER HAD TO BE REMOVED AND A NEW CATHETER WAS NEEDED. PROCEDURE COMPLETED SUCCESSFULLY AND PATIENT TRANSFERRED TO RECOVERY AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393773 ↗
• InjuryOct 13, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT A SNARE WAS USED TO REMOVE A COIL AFTER THE COIL PRE-MATURELY DETACHED INSIDE A CATHETER. THIS COIL DETACHED WHEN PULLING THE COIL BACK TO REPOSITION THE COIL DURING AN EMBOLIZATION JUST DISTAL OF THE CONFLUENCE OF THE OVARIAN, RENAL AND LUMBAR VEINS TO PREVENT REFLUX. THE COIL WAS ADVANCED THROUGH THE CATHETER AND WAS APPROXIMATELY 3/4 OF THE WAY OUT OF THE CATHETER INTO THE VEIN WHEN THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL BY PULLING IT BACK INTO THE CATHETER. AS IT WAS PULLED BACK, THE COIL DETACHED PRE-MATURELY INSIDE THE CATHETER. THE PHYSICIAN TRIED TO SLOWLY ADVANCE THE CATHETER TO REPOSITION THE COIL. THE COIL CAME OUT OF THE CATHETER AND A PORTION OF THE COIL WAS VISIBLE IN THE RENAL VEIN. THE PHYSICIAN WAS ABLE TO SNARE THE COIL AND SUCCESSFULLY REMOVE THE COIL FROM THE PATIENT. THERE WAS NO REPORTED PATIENT IMPACT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601484 ↗
• InjurySep 12, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE POST DEPLOYMENT OF FOUR COILS IT WAS NOTICED THAT A MICROFILAMENT WAS HANGING IN THE VESSEL PROXIMAL TO THE COIL PACK. THE MICROFILAMENT WAS SNARED AND RETRIEVED INTO THE CATHETER. IT WAS OBSERVED THAT IT WAS STILL ATTACHED TO ONE OF THE COILS IN THE COIL PACK. THE COIL WAS REMOVED INTO THE CATHETER STILL ATTACHED TO THE MICROFILAMENT. ONCE THIS WAS REMOVED SUCCESSFUL EMBOLIZATION OF THE TARGET VESSEL WAS ACHIEVED. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402882 ↗
• MalfunctionAug 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FIRST COIL USED STARTED TO UNRAVEL/STRETCH DURING PULLING FOR REPOSITIONING. THE COIL WAS REMOVED FROM THE PATIENT. THE SECOND COIL DEPLOYED DETACHED UNINTENTIONALLY DURING PULLING FOR REPOSITIONING AND COIL GOT STUCK IN THE MICROCATHETER WHEN ATTEMPTED TO MANUALLY PUSH OUT. THE ENTIRE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. PROCEDURE OUTCOME WAS SUCCESSFUL AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283715 ↗
• MalfunctionJan 21, 2022Inadequacy of Device Shape and/or Size; Unraveled Material; Inadequacy of Device Shape and/or Size; Unraveled Material

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF THE INTERNAL ILIAC ARTERY, THE PHYSICIAN OBSERVED THAT THE IMPLANT WAS LARGER THAN IT SHOULD BE AND REMOVED IT. THE IMPLANT UNRAVELED DURING REMOVAL. THERE WAS NO PATIENT HARM REPORTED OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13312274 ↗
• MalfunctionDec 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A FISTULA, AN EMBOLIZATION COIL IMPLANT DETACED PREMATURELY WITHIN THE CATHETER. THE COIL WAS REMOVED AND ANOTHER WAS USED. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058220 ↗