Azur CX Detachable 45-752039Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00812636021102), received between Mar 8, 2016 and Sep 15, 2026 — classified as 11 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (22 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Premature Separation

  As reported, during a pelvic congestion embolization in an 8mm vessel, an embolization coil implant, reported on a separate report, deployed prematurely in the glidecath and did not advance from the catheter into the vessel. The catheter was removed from the patient and the coil was pulled from the catheter outside of the body. The catheter was reintroduced and this device, a 16mm 0.035 cx coil, was opened. The same premature deployment occurred with this coil. The catheter was removed and the second coil was pulled from the catheter outside of the body. At this point the catheter was replaced with a different glidecath and the procedure continued. all coils delivered with no issues before this event and all further coils used after the catheter was replaced also delivered with no issues. The patient was not harmed. procedure was successful. patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766757 ↗
• MalfunctionJun 17, 2026Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS BEING USED IN A GDA EMBOLIZATION PROCEDURE. REPORTEDLY DURING ADVANCING THE COIL IN THE MICROCATHETER, THE COIL PREMATURELY DETACHED PRIOR TO PLACEMENT IN INTENDED SITE. IT WAS UNKNOWN WHETHER THE COILS DETACHED AT THE HUB OR MORE DISTAL IN THE MICROCATHETER. THE SAME NON TERUMO NEURO CATHETER WAS USED WITH ALL THREE COILS. THE COIL AND CATHETER WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL AT THE END OF THE PROCEDURE. THIS IS EVENT REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540853 ↗
• MalfunctionJun 6, 2026Stretched; Premature Separation

  AS REPORTED: RESISTANCE WAS FELT WHEN ADVANCING THE COIL THROUGH THE GLIDE CATHETER. THE DOCTOR TRIED TO PULL THE COIL BACK OUT OF THE CATHETER, BUT IT STRETCHED AND DETACHED FROM THE CATHETER. THE WHOLE CATHETER WAS REMOVED WITH THE COIL INSIDE. A NEW COIL WAS USED WITHOUT FURTHER ISSUES. THE SAMPLE IS NOT AVAILABLE AND WAS DISCARDED BY THE CUSTOMER. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THIS REPORT ADDRESSES THE FIRST COIL. THE SECOND COIL WILL BE REPORTED IN A SEPARATE SUBMISSION THAT REFERENCES A DIFFERENT MFR REPORT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418348 ↗
• MalfunctionApr 23, 2026Premature Separation

  IT WAS REPORTED THAT DURING A SPLENIC ARTERY PROCEDURE USING A GLIDE CATHETER, THE COIL WAS PARTIALLY ADVANCED AND THEN RETRACTED INTO THE CATHETER FOR REPOSITIONING. THE COIL DETACHED DURING RETRACTION WITHIN THE MICROCATHETER. THE PHYSICIAN SUCCESSFULLY REMOVED THE CATHETER WITH THE COIL INSIDE. THE CASE WAS COMPLETED WITH OTHER COILS. IT WAS REPORTED THAT THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975312 ↗
• MalfunctionFeb 20, 2026Component Missing

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL WAS OPENED FOR USE. WHEN IT WAS DEPLOYED, THEY FOUND UNDER X RAY THAT THERE WAS NO COIL ON THE PUSHER ROD. THE DEVICE WAS REMOVED, AND IT WAS CONFIRMED THAT NO COIL WAS PRESENT. THERE WAS NOTHING IN THE HOOP EITHER. ANOTHER COIL WAS USED. THE PATIENT IS FINE. ADDITIONAL INFORMATION RECEIVED STATED THAT IT IS UNCERTAIN HOW THEY PRETESTED THE COIL PRIOR TO INSERTION INTO THE PATIENT. HOWEVER, THEY DID HUB THE DEVICE TO THE CATHETER. THEN, IT WAS PUSHED FROM THE BACK UNTIL THE SHEATH REACHED THE DELIVERY PUSHER'S GOLD CONNECTOR, AND IT WAS REMOVED. ONCE IT WAS IN, THEY NOTICED THERE WAS NO COIL ATTACHED TO THE PUSHER ROD. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405938 ↗
• InjuryNov 7, 2025Stretched; Premature Separation; Stretched; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503896 ↗
• InjuryNov 4, 2025Stretched; Premature Separation; Stretched; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471973 ↗
• MalfunctionOct 24, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN INTERNAL ILIAC BRANCH EMBOLIZATION PROCEDURE, THE COIL BROKE OFF OF THE PUSHER WIRE, BUT WAS RETRIEVED FROM INSIDE THE 5FR GLIDECATHETER. ADDITIONAL COILS WERE ADDED, AND PATIENT OUTCOME WAS GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383828 ↗
• MalfunctionSep 15, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING A SPLENIC EMBOLIZATION WITH LEFT RADIAL ACCESS A 105CM DSS WAS PLACED INTO THE SPLENIC ARTERY. MULTIPLY COILS WERE DEPLOYED INTO THE OUTFLOW VESSEL (AZUR CX 035 6-10MM) SUCCESSFULLY WITH THE NAVI 135CM. WHEN THE 135CM NAVI WAS ADVANCED INTO THE 4.5CM ANEURYSM FOR COIL EMBOLIZATION. WHEN ADVANCING THE 20MMX39CM (LOT#0001089719) COIL INTO THE ANEURYSM VIA THE NAVI, THE COIL WAS PUSHING SMOOTHLY UNTIL IT REACHED THE TIP OF THE NAVI. AT THIS POINT WHEN THE DOCTOR WENT TO RETRACT THE COIL IT DETACHED INSIDE THE NAVI. HE TRIED TO PUSH THE COIL WITH A 035 WIRE BUT IT WOULD NOT ADVANCE ALL THE WAY OUT INTO THE ANEURYSM. HE DECIDED TO PULL THE COIL & NAVI OUT. THE COIL WAS REMOVED SUCCESSFULLY INSIDE THE NAVI. HE WANTED TO OPEN UP ANOTHER NAVI CATHETER TO USE FOR DELIVERING THE COILS. ANOTHER 20MMX39CM COIL WAS OPENED & THIS COIL WAS DEPLOYED INTO THE SAC BUT THE COIL HAD A VERY HARD TIME TRACKING. AT THIS POINT WE TRIED ANOTHER 20MMX39MM COIL (LOT#0001101668) VIA THE NAVI & THIS COIL HAD TROUBLE TRACKING & ADVANCING THROUGH THE NAVI TIP. WHEN THE DOCTOR WENT TO RETRACT THE COIL, IT ALSO DETACHED. HE HAD TO REMOVE THE NAVI & COIL. THE COIL WAS REMOVED SUCCESSFULLY AT THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050692 ↗
• MalfunctionSep 15, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING A SPLENIC EMBOLIZATION WITH LEFT RADIAL ACCESS A 105CM DSS WAS PLACED INTO THE SPLENIC ARTERY. MULTIPLY COILS WERE DEPLOYED INTO THE OUTFLOW VESSEL (AZUR CX 035 6-10MM) SUCCESSFULLY WITH THE NAVI 135CM. WHEN THE 135CM NAVI WAS ADVANCED INTO THE 4.5CM ANEURYSM FOR COIL EMBOLIZATION. WHEN ADVANCING THE 20MMX39CM (LOT#0001089719) COIL INTO THE ANEURYSM VIA THE NAVI, THE COIL WAS PUSHING SMOOTHY UNTIL IT REACHED THE TIP OF THE NAVI. AT THIS POINT WHEN THE DOCTOR WENT TO RETRACT THE COIL IT DETACHED INSIDE THE NAVI. HE TRIED TO PUSH THE COIL WITH A 035 WIRE BUT IT WOULD NOT ADVANCE ALL THE WAY OUT INTO THE ANEURYSM. HE DECIDED TO PULL THE COIL & NAVI OUT. THE COIL WAS REMOVED SUCCESSFULLY INSIDE THE NAVI. HE WANTED TO OPEN UP ANOTHER NAVI CATHETER TO USE FOR DELIVERING THE COILS. ANOTHER 20MMX39CM COIL WAS OPENED & THIS COIL WAS DEPLOYED INTO THE SAC BUT THE COIL HAD A VERY HARD TIME TRACKING. AT THIS POINT WE TRIED ANOTHER 20MMX39MM COIL (LOT#0001101668) VIA THE NAVI & THIS COIL HAD TROUBLE TRACKING & ADVANCING THROUGH THE NAVI TIP. WHEN THE DOCTOR WENT TO RETRACT THE COIL, IT ALSO DETACHED. HE HAD TO REMOVE THE NAVI & COIL. THE COIL WAS REMOVED SUCCESSFULLY AT THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050661 ↗
• InjuryAug 12, 2025Entrapment of Device; Stretched; Premature Separation; Entrapment of Device; Stretched; Premature Separation

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING EMBOLIZATION OF A HYPOGASTRIC ANEURYSM. A GUIDING SHEATH WAS BEING USED FROM R FEMORAL ARTERY ACCESS. UP AND OVER BIFURCATION SO RELATIVELY NO TORTUOSITY INTO HYPOGASTRIC ANEURYSM. AZUR CX35 20MMX39CM WAS INSERTED INTO 4FX100CM ANG GLIDECATH. DURING ADVANCEMENT OF COIL INTO CATHETER, COIL BECAME STUCK WITH ABOUT 5-10 CM OUTSIDE OF CATHETER INSIDE ANEURYSM. THE PHYSICIAN COULD NOT ADVANCE OR RETRACT UNTIL PULLING BACK HARD ENOUGH CAUSED COIL TO BECOME DETACHED AND PUSHER WIRE WAS REMOVED WITH COIL STILL STUCK IN CATHETER. THE BACK END OF A GUIDEWIRE WAS INSERTED TO ADVANCE COIL BUT WAS UNSUCCESSFUL. WIRE BENT AND PHYSICIAN TRIED ANOTHER GUIDEWIRE TO ADVANCE AND WAS UNSUCCESSFUL AGAIN. CATHETER WAS REMOVED AND COIL STAYED STUCK IN PLACE. PHYSICIAN DID PULL COIL FROM THE DISTAL TIP WHEN CATHETER WAS OUTSIDE OF BODY AND COIL STRUNG OUT BUT REMAINED STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786522 ↗
• MalfunctionJun 26, 2025Premature Separation; Premature Separation

  AS REPORTED, THE PHYSICIAN GAINED ACCESS AND NAVIGATED DELIVERY CATHETER TO LOCATION. INSERTED THE COIL INTO THE MICROCATHETER. WHEN DELIVERING PHYSICIAN FELT RESISTANCE DUE TO THE EXTREME TORTUOSITY OF THE VESSEL. COIL DETACHED FROM PUSHER WIRE WITHIN CATHETER. THE COIL AND CATHETER WERE REMOVED AND THE PROCEDURE WAS CONTINUED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342681 ↗
• MalfunctionMar 28, 2025Premature Separation; Premature Separation

  IT WAS REPORTED: WHEN ADVANCING THE COIL INTO THE BASE CATHETER THE COIL WAS NOT COMING OUT OF THE DISTAL END OF THE BASE CATHETER. THE PUSHER WIRE WAS ALMOST HUBBED AND THE DENSE COIL WAS NOT SHOWING ON THE SCREEN. THE PHYSICIAN WAS MANIPULATING THE COIL IN ORDER TO TRY AND GET IT PLACED IN A CERTAIN SPOT. THE COIL DID COME OUT OF THE CATHETER BUT NOT COMPLETELY BEFORE IT PREMATURELY DEPLOYED. THE DEVICE SEEMS TO HAVE UNRAVELED AS SMALL WIRE SEEMED TO BE COMING OUT OF THE DISTAL END OF THE CATHETER. THE COIL WAS REMOVED BECAUSE IT WAS IN A HIGH FLOW VESSEL AND PHYSICIAN DIDN'T FEEL COMFORTABLE OF THE PLACEMENT OF COIL THAT WAS HANGING OUT. THE COIL WAS REMOVED WITH BACK SUCTION ON THE CATHETER WITH A SYRINGE AND THEY PULLED THE WHOLE SYSTEM OUT. AS THEY HAD ALREADY PLACED AN AMPLATZER PLUG AND ONE COIL WHICH SEEMED TO SLOW IT DOWN, THE PROCEDURE WAS DONE AT THAT POINT. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721801 ↗
• MalfunctionNov 27, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE CARTO PROCEDURE, THE COIL INADVERTENTLY DETACHED WHILE BEING DEPLOYED THROUGH A 4F 100CM ANGLED GLIDECATHETER. THE PHYSICIAN REMOVED THE COIL AND THE GLIDECATHETER TOGETHER. NO NEGATIVE EFFECT TO THE PATIENT. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799521 ↗
• MalfunctionNov 15, 2024Stretched; Premature Separation; Stretched; Premature Separation

  SEE H11. CHANGE TO SECTION: H6- MEDICAL DEVICE PROBLEM CODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696932 ↗
• MalfunctionOct 19, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED IN THE CATHETER. THE COIL AND CATHETER WERE BOTH REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT COIL OF THE SAME TYPE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20489242 ↗
• MalfunctionJul 24, 2024Stretched; Premature Separation; Stretched; Premature Separation

  THE COIL WAS INITIALLY DEPLOYED, BUT THE MD WANTED TO REPOSITION THE COIL. WHEN TRYING TO REPOSITION THE COIL, IT STARTED TO UNWIND AT THE PRIMARY WIND AND THEN PREMATURELY DETACHED WITHIN THE CATHETER. AT THIS POINT, THE MD SAFELY REMOVED THE CATHETER WITH THE COIL INSIDE IT. THERE WAS NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822974 ↗
• InjuryJul 10, 2024Premature Separation; Premature Separation

  AS REPORTED: DURING THE REPAIR OF A SPLENIC ANEURYSM, THE COIL PREMATURELY DETACHED PRIOR TO USING THE DETACHMENT CONTROLLER. A PORTION OF THE COIL RESIDED IN THE ANEURYSM ITSELF WHILE THE REMAINDER OF THE COIL REMAINED IN THE INFLOW PORTION OF THE SPLENIC ARTERY. THE PHYSICIAN WAS COMFORTABLE WITH KEEPING THIS PORTION OF THE COIL IN THIS ANATOMICAL LOCATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716295 ↗
• InjuryMar 5, 2024Premature Separation; Premature Separation

  AS REPORTED, THE COIL STUCK INSIDE THE MICRO-CATHETER AFTER DEPLOYMENT. WHEN RETRACTED, A PIECE OF THE COIL OR PUSHER WIRE REMAINED INSIDE THE CATHETER. A SNARE DEVICE WAS USED TO REMOVE THE SMALL PIECE THAT WAS HANGING FREE INSIDE THE CATHETER. PATIENT OUTCOME WAS REPORTED SUCCESSFUL, STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842890 ↗
• InjuryNov 7, 2023Stretched; Premature Separation; Stretched; Premature Separation

  ADDITIONAL EVENT INFORMATION WAS RECEIVED, THE CX COIL WAS ADVANCED BUT PREMATURELY DETACHED AND THEN THE OUTER FIBER DID NOT DELIVER. WE ATTEMPTED TO PUSH THIS, FLUSH THIS, AND RETRACTION IS WITH A COMBINATION OF WIRE AND CATHETERS. ULTIMATELY, WE WERE ABLE TO PUSH THE OUTER FIBER OUT OF ARTERIAL GUIDE CATHETER BUT A PORTION OF THE OUTER FIBER REFLUX INTO THE HEPATIC AND CELIAC ARTERY. AFTER PROLONGED EFFORTS WE ADVANCED A 7 MM SNARE AND WERE ABLE TO SNARE THE FIBER OF THE COIL AND RETRACTED THE COIL ENTIRETY BACK INTO THE SHEATHS AND DELIVERED FROM OUR TOURGUIDE. THE PROCEDURE WAS DELAYED AND THE PATIENT WAS DISCHARGED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083312 ↗
• MalfunctionSep 29, 2023Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED DURING A PRE-EVAR CASE, THE COIL UTILIZATION WAS IN REGARD TO A VESSEL SHUT DOWN OF THE RIGHT HYPOGASTRIC ARTERY IN AN ANEURYSMAL SECTION AND PREMATURELY DETACHED. THE PHYSICIAN INTENDED TO USE COILS TO CREATE A BACKSTOP IN THE DISTAL HEALTHY PORTION OF THE VESSEL, AND THEN PACK IN THE ANEURYSMAL SECTION WITH ADDITIONAL COILS. THE COIL AND ONE DETACHMENT CONTROLLER WERE BROUGHT INTO THE STERILE FIELD VIA NECESSARY METHODS. AT NO POINT WAS THE DETACHMENT CONTROLLER USED OR TESTED ON THE COIL. AFTER REMOVING THE COIL FROM ITS PACKAGING, FLUSHING, INTRODUCING THE SHEATH INTO THE BASE CATHETER AND REMOVING THE BLACK STOPPER, THE TECH STARTED ADVANCING THE PUSHER WIRE. ALMOST IMMEDIATELY, PHYSICIAN CLAIMED THAT THE COIL WAS "DEPLOYING WITHIN THE BASE CATHETER" AND HAD BECOME DETACHED FROM THE PUSHER WIRE. IT LOOKED LIKE THE PHYSICIAN HAD ADVANCED THE INTRODUCER SHEATH TOO FAR INTO THE BASE CATHETER AND HAD POSSIBLY CAUSED CRIMPING OF THE COIL. THE PHYSICIAN THEN REMOVED THE PUSHER WIRE FROM THE SYSTEM TO SHOW THAT IT HAD INDEED COME DETACHED FROM THE COIL. THEN REMOVED THE INTRODUCER SHEATH FROM THE BASE CATHETER AND PROCEEDED TO PULL THE COIL OUT MANUALLY. THIS CAUSED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849014 ↗
• InjuryJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE USING THE TRANSJUGULAR APPROACH FOR A VENOUS ANEURYSM, RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THE COIL GOT STUCK. THE COIL WAS PULLED BACK AND ADVANCED AGAIN AND FOUND A LARGER PORTION OF THE COIL WAS COMPLETELY IN THE ANEURYSM UNDER PERFUSION. THE PROXIMAL PORTION OF THE PUSHER WAS DAMAGED AND PREMATURELY DETACHED INSIDE THE CATHETER WHILE ATTEMPTING TO PULL THE COIL BACK AND WAS RECOVERED WITH A GOOSE NECK SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER COILS. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076374 ↗
• MalfunctionApr 25, 2023Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT DURING A BARTO PROCEDURE, THE EMBOLIZATION COIL ENCOUNTERED RESISTANCE WITHIN THE CATHETER. DURING ATTEMPT TO REMOVE THE COIL, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE CATHETER WAS VIEWED UNDER FLUORO CONFIRMING THE COIL REMAINED IN THE CATHETER. THE COIL AND CATHETER WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811935 ↗
• MalfunctionMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582617 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549664 ↗