Azur CX Detachable 45-750609Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00812636021034), received between Apr 27, 2017 and Jul 8, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Stretched; Difficult to Advance; Premature Separation; Stretched; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT DURING A LEFT GONADAL VEIN EMBOLIZATION, THE PHYSICIAN DETERMINED WHERE TO DEPLOY THE COIL, AND THAT COIL HAD DEPLOYED NORMALLY. THEN, ANOTHER UPSIZED COIL WAS USED. THE PHYSICIAN STARTED TO PUSH IT THROUGH THE CATHETER AND ENCOUNTERED RESISTANCE. HE TRIED TO MANIPULATE THE COIL AND THE CATHETER, BUT STILL ENCOUNTERING RESISTANCE. UPON REMOVING THE COIL, THE PHYSICIAN STATED THAT HE FELT A POP, AND THE COIL HAD DETACHED INSIDE THE CATHETER. WITH THE COIL FULLY WITHIN THE CATHETER, THE CATHETER WAS REMOVED. THE CATHETER WAS FLUSHED, AND THE COIL CAME OUT ONTO THE STERILE FIELD. UPON FLUSHING OUT, THE PHYSICIAN NOTED THAT THE COIL STARTED TO UNRAVEL. A QUICK FLUOROSCOPIC IMAGE SHOWED NO PARTS OFF THE COIL WERE LEFT BEHIND. THE PHYSICIAN FINISHED THE CASE. THERE WAS NO PATIENT INJURY NOR SURGICAL INTERVENTION. THE PATIENT WAS DISCHARGED THE SAME DAY WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22442604 ↗
• MalfunctionMay 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL, AND THE PATIENT STABLE WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850719 ↗
• MalfunctionMar 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE, WHILE USING A 4FR GLIDE CATHETER, THE COIL WOULD NOT ADVANCE OUT OF THE GLIDE CATHETER. UPON RETRACTING THE COIL, IT UNINTENTIONALLY DETACHED HALFWAY IN THE CATHETER AND PARTIALLY OUT OF THE CATHETER. THE COIL WAS REMOVED WITH THE CATHETER IN ITS ENTIRETY. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO INTERVENTION OF PATIENT HARM. THE PATIENT CONDITION IS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526963 ↗
• InjuryJul 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DELIVERY OF THE COIL, THE COIL UNINTENTIONALLY DETACHED INSIDE THE PATIENT BEFORE THEY WERE ABLE TO REACH THE TREATMENT SITE. THE COIL WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. THE PROCEDURE WAS CONTINUED WITH ADDITIONAL COILS WITH NO FURTHER ISSUES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION, AND PROCEDURE OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112397 ↗
• MalfunctionJun 24, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE VASCULAR EMBOLIZATION COIL IMPLANT WAS USED IN A PROCEDURE FOR TREATING A CEPHALIC VEIN BRANCH TO BETTER THE FLOW IN A LOWER LEFT FOREARM NATIVE FISTULA. ONCE ACCESS WAS GAINED TO THE TARGET CITE, ONE COIL WAS SUCCESSFULLY DEPLOYED IN NORMAL FASHION WITHOUT ANY ISSUES. THE PHYSICIAN THEN DETERMINED ANOTHER COIL WAS NEEDED TO FULLY SHUT DOWN FLOW IN THE SIDE BRANCH. A SECOND COIL WAS THEN OPENED AND DELIVERED THROUGH THE SAME MICROCATHETER AND DEPLOYED IN NORMAL FASHION. THE PROCEDURE WAS COMPLETED WHEN THE PHYSICIAN NOTICED A SHORT FILAMENT OF THE 6X9 COIL THAT HAD UNRAVELED FROM THE MAIN COIL PACK. IT WAS STILL ATTACHED BUT OUT OF POSITION. SEVERAL ATTEMPTS WERE MADE USING DIFFERENT DEVICES TO PUSH THE FILAMENT INTO THE COIL PACK AND BACK INTO POSITION, BUT THESE ATTEMPTS FAILED. A SNARE DEVICE WAS THEN PASSED WITH ADDITIONAL ATTEMPTS TO PUSH THE FILAMENT BACK INTO PLACE, WHICH WAS SUCCESSFUL. ALL WIRES AND PRODUCTS WERE REMOVED WITH SOME FINAL RUNS UNDER FLUOROSCOPY CONFIRMING THE COIL FILAMENT WAS MAINTAINING POSITION WITHIN THE MAIN COIL PACK. REPORTEDLY, THE PATIENT WAS IN GOOD CONDITION AT THE END OF THE PROCEDURE AND WAS SENT TO RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063373 ↗
• MalfunctionSep 11, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT AFTER PLACEMENT AT THE TREATMENT SITE, THE FIRST EMBOLIZATION COIL WAS DETACHED WITH THE CONTROLLER; HOWEVER, A SUBSEQUENT COIL COULD NOT BE ADVANCED THROUGH THE CATHETER. THE CATHETER WAS REMOVED AND THE FIRST COIL WAS DISCOVERED TO BE STUCK ON THE END OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10525835 ↗
• MalfunctionSep 5, 2020Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS ATTEMPTED IN A SPLENIC ARTERY. THE ANATOMY WAS VERY TORTUOUS AND IT WAS DIFFICULT FOR THE COIL TO NAVIGATE THE VESSEL. AFTER SEVERAL ATTEMPTS TO MANIPULATE AND REPOSITION THE COIL, THE PUSHER WIRE DETACHED INSIDE THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY TOGETHER WITH THE CATHETER. THERE WAS NO PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT WAS REPORTED TO BE "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497928 ↗
• MalfunctionAug 22, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A FISTULA COLLATERAL, THE EMBOLIZATION COIL WOULD NOT ADVANCE OUT OF THE CATHETER TIP OR RETRACT. IT WAS DETERMINED THAT THE COIL DETACHED. THE COIL COULD NOT BE ADVANCED WITH A PUSHER, AND SO THE ENTIRE CATHETER WAS REMOVED WITH THE IMPLANT COIL. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923747 ↗
• MalfunctionOct 13, 2017Detachment Of Device Component; Stretched; Detachment Of Device Component; Stretched

  IT WAS REPORTED THAT AN EMBOLIZATION COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER WITHOUT USE OF THE CONTROLLER. THE COIL WAS STRETCHED; THE PHYSICIAN WAS UNABLE TO PUSH THE COIL OUT OF THE MICROCATHETER WITH A GUIDEWIRE OR SALINE FLUSH. BOTH SEGMENTS OF THE COIL WERE WITHDRAWN TOGETHER WITH THE MICROCATHETER, AND REMOVED IN THEIR ENTIRETY. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950001 ↗
• MalfunctionJul 29, 2017Detachment Of Device Component; Migration or Expulsion of Device; Difficult to Remove; Detachment Of Device Component; Migration or Expulsion of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL WAS ADVANCED WITHOUT RESISTANCE THROUGH A MICROCATHETER. AS THE COIL WAS BEING POSITIONED AND MANIPULATED INSIDE THE ANEURYSM UNDER FLUOROSCOPY, THE COIL UNEXPECTEDLY DETACHED WITHOUT USE OF THE CONTROLLER. A FEW SECONDS LATER, THE COIL MIGRATED OUTSIDE THE ANEURYSM WITH THE FORCE OF THE PATIENT'S BLOOD FLOW. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL WITH A VASCULAR SNARE DEVICE; HOWEVER, IT WAS UNSUCCESSFUL. THE FOLLOWING DAY, ANOTHER ATTEMPT WAS MADE TO RETRIEVE THE COIL WITH AN ALLIGATOR RETRIEVAL DEVICE; HOWEVER, WHEN THE COIL WAS CAPTURED, IT BROKE INTO TWO (2) PARTS. ONE PART MIGRATED TO THE HUMERAL ARTERY AND WAS SURGICALLY REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6752962 ↗
• MalfunctionJun 16, 2017Detachment Of Device Component; Unraveled Material; Detachment Of Device Component; Unraveled Material

  IT WAS REPORTED THAT AN EMBOLIZATION COIL UNEXPECTEDLY DETACHED DURING Y-90 MAPPING. IT WAS STATED THAT 50% OF THE COIL WENT IN THE GASTRODUODENAL ARTERY (GDA) AND 50% OF THE COIL IN THE COMMON HEPATIC ARTERY, AND IT UNRAVELED TO THE FEMORAL ARTERY. THE COIL WAS RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648947 ↗
• InjuryApr 27, 2017Difficult to Remove; Unraveled Material; Device-Device Incompatibility; Difficult to Remove; Unraveled Material; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT OF A LEFT GROIN A-V FISTULA, THE COIL "STUCK TO A JB4 CATHETER" AND UNCOILED. THE COIL WAS REMOVED FROM THE PATIENT WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT PATIENT'S STATUS IS REPORTED TO BE "FINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525768 ↗
• MalfunctionApr 27, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A LEFT GROIN A-V FISTULA, THE EMBOLIZATION COIL BROKE OFF IN A BERN CATHETER AND APPEARED TO SEPARATE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE CURRENT PATIENT'S STATUS IS REPORTED TO BE "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525753 ↗