Azur CX Detachable 45-750617Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00812636021041), received between Mar 8, 2016 and Sep 25, 2026 — classified as 27 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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 76 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906071 ↗
• MalfunctionSep 24, 2026Premature Separation

  As reported: The coil detached from the wire inside the support catheter. The coil and catheter could not be used anymore. No patient injury.Additional information: The coil was removed by retracting the catheter. Also when "[physician]" wanted to pick up the failed coil, it was not available. Only the catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884958 ↗
• MalfunctionJun 4, 2026Premature Separation

  AS REPORTED, THE COIL WAS DELIVERED THROUGH THE CATHETER; HOWEVER, THE COIL DETACHED PREMATURELY WITHIN THE CATHETER. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT. A NEW COIL WAS OPENED, AND THE SAME CATHETER WAS REPOSITIONED INTO THE INTERNAL ILIAC OUTFLOW ARTERY. THE NEW COIL WAS DEPLOYED WITHOUT ISSUE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402688 ↗
• InjuryApr 20, 2026Material Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE A HYPOGASTRIC ARTERY THROUGH A 5FR COBRA GLIDECATH. DURING THE DELIVERY OF THE COIL TO THE TARGET AREA THE COIL SPONTANEOUSLY DETACHED AND THE WIRES THAT DELIVERY THE ELECTROTHERMAL ENERGY STAYED CONNECTED TO THE GLUE SPOT AND STRUNG OUT AS THE PUSHER WIRE WAS WITHDRAWN. THEY WERE ABLE TO SNARE THE COIL AND REMOVE IT FROM THE PATIENT. THE PATIENT IS STABLE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931402 ↗
• MalfunctionApr 17, 2026Unraveled Material; Premature Separation

  AS REPORTED: THE COIL UNRAVELED WHILE DEPLOYING. THE COIL UNEXPECTEDLY DETACHED. THE COIL DETACHED INSIDE THE CATHETER WHILE INSIDE THE BODY. SOME OF THE COIL FORMED LIKE NORMAL AND THE REST UNRAVELED. SOME OF THE COIL WAS INTACT AND REMOVED FROM THE CATHETER. NO SNARE WAS USED FOR REMOVAL. SOME OF THE COIL STAYED INSIDE THE BODY. CASE WAS COMPLETED BY USING MORE COILS. THE PATIENT IS TOTALLY FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912434 ↗
• InjuryFeb 19, 2026Unintended Movement; Premature Separation

  NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393557 ↗
• MalfunctionDec 20, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED INSIDE CATHETER WITHOUT USE OF DETACHMENT CONTROLLER. THE CATHETER WAS REMOVED WITH THE COIL INSIDE. THE CASE WAS SUCCESSFULLY COMPLETED WITH A NEW CATHETER AND COMPETITOR COILS. IT WAS REPORTED THAT THE PATIENT "IS DOING WELL ¿ NO ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860180 ↗
• MalfunctionNov 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT PRIOR TO PLACING A STENT IN THE LEFT ILIAC LIMB, THE PHYSICIAN WANTED TO COIL INSIDE THE ANEURYSMAL HYPOGASTRIC BEFORE COVERING IT WITH A STENT. WHEN THE GLIDE CATHETER WAS PROPERLY PLACED INSIDE OF THE HYPOGASTRIC, THE PHYSICIAN WANTED TO START WITH A 6 BY 17 EMBOLIZATION COIL. BEFORE DETACHING, THEY WANTED TO ADJUST THE COIL A BIT. AT THIS POINT, THE EMBOLIZATION COIL IMPLANT DETACHED ON ITS OWN WHEN IT WAS ONLY HALFWAY OUTSIDE THE GLIDE CATHETER. IT WAS THEN JUST FLUSHED IT OUT WITH SALINE AND THEY PROCEEDED WITH THREE MORE COILS TO FINISH THIS ASPECT OF THE PROCEDURE. THERE WAS NO INJURY OR INTERVENTION. THE PATIENT CONDITION WAS REPORTED TO BE "GREAT! THE END OUTCOME OF THE PROCEDURE TURNED OUT VERY WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624837 ↗
• InjuryOct 17, 2025Premature Separation; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331043 ↗
• InjuryAug 21, 2025Premature Separation; Premature Separation

  AS REPORTED: EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY. THERE WAS NO CANCELLATION OF THE CASE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866002 ↗
• MalfunctionMay 30, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS COILING AN INTERNAL ILIAC ARTERY USING A CATHETER. HE SAID THAT AS HE WAS DEPLOYING THE COIL IT SUDDENLY STOPPED DEPLOYING AND GOT "STUCK" IN THE CATHETER. HE PULLED BACK AND THE COIL SEPARATED WITHIN THE CATHETER, AND HE SAID THE FILAR OF COIL JUST KEPT COMING OUT. HE PULLED THE CATHETER OUT AND THE REST OF THE COIL CAME OUT OF THE BODY AS WELL. HE RE-INTRODUCED THE CATHETER AND PROCEEDED TO DEPLOY 3 MORE COILS WITHOUT ISSUE. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120259 ↗
• MalfunctionMay 9, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS BEING MANIPULATED FOR BETTER POSITIONING PRIOR TO DEPLOYMENT WHEN IT STRETCHED OUT AND DETACHED IN THE CATHETER. A WIRE WAS USED TO PUSH THE COIL OUT OF THE CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO CONCERN FOR NONTARGET EMBOLIZATION OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998223 ↗
• MalfunctionJan 8, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A SCHEDULED EMBOLIZATION OF AN INTERNAL ILIAC VESSEL WITH A COVERED STENT PLACED ACROSS THIS VESSEL, THE COIL WAS ADVANCED IN CATHETER AND WOULDN'T ADVANCE OUT OF CATHETER. AFTER SOME STRUGGLE THE PHYSICIAN PULLED OUT AND THE COIL LOOKED TO BE DETACHED FROM THE PUSHER WIRE BUT STILL CONNECTED TO THE FILAMENT WIRE. THE PRODUCT WAS REMOVED; THE CATHETER WAS LEFT IN PLACE AND OTHER 035 CX COILS WERE PLACED THROUGH THE SAME CATHETER AND CASE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHERE OR WHEN DETACHED AS COIL WAS INSERTED INTO CATHETER FROM COIL HOUSING SHEATH, SO COIL WAS NEVER OBSERVED BEFORE INSERTING INTO THE CATHETER. THE COIL DID LOOK TO HAVE DETACHED FROM THE PUSHER WIRE BUT COULDN¿T NOT TELL WHERE. THE PATIENT WAS REPORTED TO BE STABLE AT THE CLOSE OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105545 ↗
• InjuryDec 17, 2024Premature Separation; Premature Separation

  PLEASE SEE H6 AND H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20959214 ↗
• MalfunctionDec 10, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY INSIDE A CATHETER LUMEN. THE COIL WAS REMOVED SUCCESSFULLY WITHOUT INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894686 ↗
• InjuryNov 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649366 ↗
• MalfunctionNov 7, 2024Unraveled Material; Separation Failure; Unraveled Material; Separation Failure

  AS REPORTED: THE COIL COULD BE INSERTED AND PLACED IN THE VESSEL VIA THE CATHETER WITHOUT ANY PROBLEMS; DETACHMENT WITH THE CONTROLLER ALSO WENT AS USUAL. THE WIRE COULD BE WITHDRAWN WITHOUT RESISTANCE AND WITHOUT MOVING THE COIL. DURING THE VISUAL INSPECTION BEFORE INSERTING THE NEXT COIL, AN APPROXIMATELY 12CM LONG PIECE OF THE COIL (PULLED INTO THE LENGTH) WAS FOUND IN THE END PIECE OF THE INSERTED CATHETER. THIS DEFECTIVE PART OF THE COIL PROTRUDED INTO THE BRACHIOCEPHALIC TRUNK AND COULD BE RETRIEVED FROM THE PATIENT TOGETHER WITH THE REMAINING COIL. THE SAME SIZE WAS TAKEN FROM THE CONSIGNMENT STORE AGAIN AND FITTED WITHOUT ANY PROBLEMS. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635317 ↗
• InjuryOct 3, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WITH VARICEAL EMBOLIZATION, THE COIL PREMATURELY DETACHED WHEN BEING REPOSITIONED AND COULD NO BE RETRACTED. A SNARE DEVICE WAS USED TO RETRIEVE THE COIL INTO THE BASE CATHETER. A NEW CATHETER AND TWO MORE COILS OF THE SAME MODEL AND SIZE WERE SELECTED AND USED SUCCESSFULLY TO COMPLETE THE CASE. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363720 ↗
• MalfunctionSep 25, 2024Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  AS REPORTED: COIL WAS PASSED THROUGH A 5FR CATHETER AND PULLED BACK INTO THE CATHETER, THEN PUSHED OUT AGAIN TO BE PULLED BACK A SECOND TIME. WITH THE SECOND PULL BACK, THE COIL BECAME STUCK AND THE MD CONTINUED TO PULL UNTIL THE PUSHER WIRE BROKE. THE CATHETER WAS PULLED OUT OF THE PATIENT WITH THE COIL STUCK IN THE END OF THE CATHETER. UPON VISUAL INSPECTION AND UNDER FLUOROSCOPY, THE MD BELIEVES ALL OF THE COIL WAS REMOVED. THE COIL WAS PASSED ALL THE WAY OUT THE END OF THE CATHETER INTO TO PATIENT AND THEN THE ATTEMPT TO PULL THE COIL BACK OUT OF THE PATIENT WAS MADE. THERE WAS NO ATTEMPT TO DETACH THE COIL WITH THE DETACHMENT DEVICE. THE COIL AND PUSHER WIRE WAS BROKEN INSIDE THE CATHETER WITH THE COIL PARTIALLY STICKING OUT OF THE CATHETER ALL WHILE INSIDE THE PATIENT. TYPE OF PROCEDURE PERFORMED: SPLENIC ANEURYSM EMBOLIZATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306709 ↗
• MalfunctionSep 23, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT A PREMATURE DETACHMENT COIL WAS REMOVED AND NEW ONE DELIVERED, CASE COMPLETED. IT WAS REPORTED THAT THE PATIENT WAS STABLE AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276384 ↗
• MalfunctionJun 20, 2024Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT DURING GASTRIC VARICES EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL PREMATURELY DETACHED IN THE MICROCATHETER AND PART OF THE COIL WAS OUT OF THE CATHETER. THERE WAS MINIMAL TORTUOSITY AND TWO OTHER COILS WERE INITIALLY DEPLOYED. THE CATHETER AND COIL WERE REMOVED WITH COIL HALF OUT AND STRETCHED. THE CASE WAS COMPLETED WITH USE OF OTHER BRAND COIL SYSTEM. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575723 ↗
• MalfunctionApr 19, 2024Premature Separation; Premature Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149639 ↗
• MalfunctionDec 21, 2023Premature Separation; Premature Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380550 ↗
• InjuryNov 29, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED, DURING A EMBOLIZATION OF AN ANEURYSM OFF THE CELIAC TRUNK A COIL FILAMENT BROKE DURING PLACEMENT AND COULD NOT BE DETACHED. NEEDED TO SNARE AND REMOVE WITH CATHETER. THE COIL WAS UNRAVELED PROXIMALLY. AFTER THE COIL WAS SNARED AND REMOVED FROM THE PATIENT, THE CASE WAS DEEMED COMPLETE UPON FOLLOWING ANGIOGRAM. IT WAS REPORTED THERE WAS NO HEALTH DAMAGE. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232408 ↗
• InjuryOct 15, 2023Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED DURING PLACEMENT OF AN EMBOLIZATION COIL IMPLANT IN THE IMA, IT WAS OBSERVED THAT PART OF THE COIL FILAR FROM THE PRIMARY WIND CAME UNWOUND AND WAS FLOATING BACK INTO THE AORTA. THE PHYSICIAN ATTEMPTED TO REMOVE AND RE-SHEATH THE COIL AND IT UNINTENTIONALLY DETACHED AND COULD NOT BE WITHDRAWN. THE PHYSICIAN HAD TO SNARE THE COIL TO REMOVE IT AND SWITCHED TO A BALT COIL. TO DO THIS, THE PHYSICIAN PLACED A MICROCATHETER AND SUCCESSFULLY PLACED AND DEPLOYED OTHER COILS TO FINISH THE EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17937110 ↗