AZUR 45-880020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00842429118054), received between Jan 29, 2024 and Aug 25, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Premature Separation

  As reported: The coil detached early without being detached with the detacher. They were able to retrieve the coil and it was not implanted in the body. The coil was retrieved with a snare and pulled out ofthe body completely. The patient was ok, case finished with no other issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422538 ↗
• InjuryApr 30, 2026Migration; Premature Separation

  AS REPORTED: EMBO BLEED CASE OF VESSEL OFF CELIAC ARTERY, 5FR RIGHT FEMORAL ARTERY ACCESS FOLLOWED BY CATHETER, AND THEN FOLLOWED BY 0.021 MICROCATHETER TO TARGET AREA. VARIOUS COILS DEPLOYED BEFORE REPORTED COIL WAS INSERTED. COIL WAS INSERTED INTO MICROCATHETER WITHOUT INCIDENT. COIL PLACEMENT WAS NOT SATISFACTORY FOR PHYSICIAN AND RETRIEVAL OF THE COIL WAS ATTEMPTED. IT WAS DISCOVERED THAT THE COIL HAD DETACHED FROM THE DELIVERY SYSTEM. THE COIL TRAVELED TO A NON-TARGET AREA. A SMALL SNARE WAS INSERTED TO REMOVE THE HYDROPACK COIL THAT TRAVELED TO AN UNINTENDED TARGET, SUCCESSFUL REMOVAL OF HYDROPACK VIA SNARE. PATIENT STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050905 ↗
• MalfunctionApr 11, 2026Premature Separation

  IT WAS REPORTED THAT DURING A SPLENIC ANEURYSM EMBOLIZATION CASE, THERE WAS EXTREME TORTUOSITY, THE DOCTOR WAS USING A MICROCATHETER WITH AN 0.18 GT-R, THE MICROCATHETER TRACKED THROUGH THE TORTUOSITY EASILY. THE PROVIDER WAS ABLE TO DEPLOY MULTIPLE COILS THROUGH THE MICROCATHETER. HE TRIED TO DEPLOY A NON-MICROVENTION PACKING COIL AND TRIED TO MANIPULATE THE MICROCATHETER WHILE THE COIL WAS IN THE CATHETER AND ENCOUNTERED AN ISSUE WHERE THE NON-MICROVENTION COIL DETACHED PREMATURELY. THE PROVIDER WAS ABLE TO PUSH THAT COIL OUT, HE FLUSHED THE MICROCATHETER AND PERFORMED AN ANGIOGRAM. HE THEN TRIED TO ADVANCE A 20CM HYRDOPACK COIL AND ENCOUNTERED RESISTANCE. HE TRIED TO REMOVE THE HYDROPACK AND THE COIL GOT STUCK AND BROKE. HE REMOVED THE PUSHER WIRE AND THE PORTION THAT HAD BROKEN, THE COIL STARTED TO UNRAVEL BUT HE REMOVED THE MICROCATHETER WHICH HAD THE REMAINDER OF THE BROKEN COIL WITHIN IT WITH NO ISSUES. THE CASE FINISHED WITH NO OTHER ISSUES AND THE PATIENT WAS ABLE TO GO TO RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847338 ↗
• InjuryFeb 18, 2026Material Separation; Premature Separation

  AS REPORTED: DR. WAS PERFORMING A RIMA COLLATERAL EMBOLIZATION. TWO 0.018 CX COILS WERE PLACED THROUGH A 2.8F 130CM MICROCATHETER INTO THE COLLATERAL, FOLLOWED BY A 10CM HYDROPACK. A SECOND HYDROPACK, THE 20CM HYDROPACK, WAS UTILIZED. THE COIL WAS DELIVERED AND DEPLOYED COMPLETELY AS INTENDED WITHOUT ISSUE. HOWEVER, THE COIL WAS APPROXIMATELY 2MM TOO LONG. ABOUT A 2MM PORTION WAS PROTRUDING INTO THE NATIVE SUBCLAVIAN ARTERY. THE PHYSICIAN DECIDED TO SNARE THE COIL OUT AND PUT A SHORTER HYDROPACK IN. A SNARE WAS ADVANCED THROUGH A 4F CATHETER AND THE TIP OF THE HYDROPACK WAS SNARED AND PULLED BACK INTO THE 4F CATHETER. UPON REMOVING THE HYDROPACK, THE SNARE SLIPPED OFF OF THE COIL MIDWAYS THROUGH THE 4F CATHETER. CONTRALATERAL ACCESS WAS OBTAINED AND A SECOND 4F CATHETER WAS INSERTED. THE COIL PACK THAT WAS REMAINING WAS SNARED AND REMOVED THROUGH THE SECOND 4F CATHETER. HOWEVER, THE SAME INSTANCE OCCURRED. AT THIS POINT, A PORTION OF THE HYDROPACK WAS STILL DEPLOYED IN THE COLLATERAL AND 2 SECTIONS OF THE COIL WERE NOW SNARED AND INSIDE 2 SEPARATE 4F CATHETERS. ONE 4F CATHETER WAS REMOVED AND THE PRIMARY WIND OF THE COIL CAME OUT THROUGH THE 4F SHEATH IN THE GROIN. THE DR. PULLED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384708 ↗
• MalfunctionFeb 13, 2026Premature Separation

  IT WAS REPORTED DURING A GI BLEED PROCEDURE, WE ADVANCED A PROGREAT THROUGH A C1 GLIDECATH INTO THE VESSEL SHOWING MULTIPLE GI BLEEDS. WHILE TRYING TO ADVANCE THE HYDROPACK THROUGH THE PROGREAT, RESISTANCE WAS MET AND THE COIL PREMATURELY DETACHED WITHIN THE PROGREAT. UPON REMOVAL OF THE PROGREAT (WITH THE COIL STILL INSIDE THE CATHETER), A KINK WAS NOTED IN THE PROGREAT. THE PHYSICIAN BELIEVES HE MAY HAVE TIGHTENED THE TUOY TOO TIGHT ON THE CATHETER, CAUSING THE KINK. WE OPENED A NEW PROGREAT AND COIL AND FINISHED THE PROCEDURE WITHOUT INCIDENT. THE PATIENT WAS THEN TRANSFERRED TO THE FLOOR IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339763 ↗
• InjuryNov 18, 2025Premature Separation; Premature Separation

  AS REPORTED: PRE Y-90 MAPPING PROCEDURE, HYDROPACK DETACHED IN THE CATHETER, HAD TO GO IN AND SNARE THE COIL OUT. PROCEDURE WAS SUCCESSFUL POST SNARE OF COIL. NO BAD PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579297 ↗
• MalfunctionAug 14, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A TRAUMA BLEED-IR CASE. THE PERIPHERAL COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER AS THE OPERATOR WAS TRYING TO ADVANCE THE COIL INTO THE TARGETED EMBOLIZATION AREA. THE COIL AND MICROCATHETER WERE REMOVED. THE PERIPHERAL COIL WAS REMOVED FROM THE MICROCATHETER OUTSIDE OF THE PATIENT AND WAS THROWN AWAY. A MICROCATHETER WAS ADVANCED BACK TO TARGETED AREA, AND THE PROCEDURE WAS COMPLETED WITH OTHER COILS. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812420 ↗
• InjuryAug 6, 2025Premature Separation; Premature Separation

  AS REPORTED, LEFT RENAL EMBOLIZATION VIA RENEGADE HIFLOW 150CM. PLACED 7 AZUR CX .018 COILS AND ATTEMPTED TO PUT .018 HYDROPACK 20CM TO FINISH AND THE COIL BROKE AT SOLDER POINT IN MICROCATHETER, HALF IN RENAL ARTERY, HALF IN CATHETER. THE PHYSICIAN ATTEMPTED RETRIEVAL WITH A GOOSE NECK SNARE HOWEVER, UNSUCCESSFUL. PATIENT LEFT OR IN STABLE CONDITION. TYPE OF PROCEDURE PERFORMED: LEFT RENAL EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734555 ↗
• InjuryJul 14, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A GI BLEED PROCEDURE, THE HYDROPACK WAS ADVANCED INTO A 2.8 CATHETER. DURING ADVANCEMENT, THE WIRE DETACHMENT SYSTEM PREMATURELY DETACHED WHILE INSIDE THE CATHETER. AFTER DETACHMENT ERROR, THE DOCTOR THEN TRIED TO REMOVE CATHETER FROM THE BODY TO GET THE COIL OUT OF THE CATHETER; DURING PULL BACK, THE HYDROPACK STARTED MOVING INTO THE BODY / SLIDING INTO THE VESSEL. AT THIS POINT, THE DOCTOR USED A WIRE TO PUSH COIL OUT THE REST OF THE WAY INTO PATIENT / INTO THE INTENDED VESSEL, AND THE CASE WAS COMPLETE. THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503664 ↗
• InjuryMay 7, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE AZUR EMBOLIZATION COIL WAS BEING DEPLOYED THROUGH A MICROCATHETER IN AN EMBOLIZATION PROCEDURE OF THE INFERIOR MESENTARIC ARTERY. WHILE ATTEMPTING TO RETRACT THE HYDROPACK COIL BACK INTO THE MICROCATHETER FOR POSITIONING, THE COIL PREMATURELY DETACHED. THIS LEFT THE COIL IN AN UNDESIRABLE LOCATION. THEREFORE, THE OPERATING PHYSICIAN OPTED TO USE AN AMPLATZ GOOSENECK SNARE TO REMOVE THE COIL, AND IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264206 ↗
• InjuryMar 6, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A EMBOLIZATION OF RIGHT INTERNAL ILIAC BRANCH FOR AAA TYPE 2 LEAK, A COIL DETACHED AND THE TAIL WAS IN AN UNINTENDED LOCATION. A 6FR 90CM DESTINATION SHEATH WAS PLACED INTO THE LEFT BRACHIAL ARTERY AND EXTENDED INTO THE DISTAL AORTA. A COMPETITOR 035 CATHETER WAS PLACED INTO A SMALL BRANCH OFF OF THE RIGHT INTERNAL ILIAC ARTERY. A 018 GUIDEWIRE WAS PLACED. THE 2.4 COMPETITOR MICROCATHETER WAS PLACED OVER THE WIRE WITH GREAT RESISTANCE FELT BY THE TECHNOLOGIST LOADING IT. IT WAS NOTED BY THE PHYSICIAN THAT THE TECHNOLOGIST WAS ACCIDENTALLY PINNING THE CATHETER TIP AND PUSHING THE BACK END OF THE CATHETER. AFTER THE TECHNOLOGIST REPOSITIONED THEIR HANDS, THE CATHETER WAS ABLE TO BE DELIVERED TO THE APPROPRIATE LOCATION OVER THE WIRE. THE WIRE WAS REMOVED, AND THE 018 10CM HYDOPACK COIL WAS INTRODUCED. ONE COIL WAS SUCCESSFULLY DELIVERED. THE SECOND COIL WAS DELIVERED, BUT INTENDED TO BE REPOSITIONED AND UPON REMOVAL, THE COIL BECAME DETACHED DUE TO RESISTANCE AND THE TAIL OF THE COIL WAS HANGING INTO THE COMMON ILIAC ARTERY IN AN UNWANTED LOCATION. THE COMPETITOR MIROCATHETER WAS REMOVED, BUT WAS ELONGATED AND PARTIALLY TORN. THE PHYSICIAN DECIDED THAT NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852853 ↗
• MalfunctionJan 29, 2024Premature Separation; Premature Separation

  THIS IS REPORT 1 OF 1. CASE WAS A GDA EMBOLIZATION VIA RIGHT GROIN ACCESS. FIRST A .018 2X4 CX COIL WAS DEPLOYED DISTALLY IN APPROXIMATELY A 1MM VESSEL WITHOUT INCIDENT. NEXT THE COIL WAS INSERTED INTO THE MICROCATHETER. THE PHYSICIAN WAS HAVING TROUBLE GETTING THE COIL TO TAKE SHAPE AND IT DOUBLED BACK ON ITSELF 2-3 TIMES. THE PHYSICIAN WAS INSTRUCTED TO PULL BACK HIS MICROCATHETER SLIGHTLY TO RELEASE THE TENSION. THE PHYSICIAN THEN SAID HE FELT A POP AND THE COIL DETACHED WITH ONLY ABOUT 1/3 OF THE COIL OUTSIDE OF THE MICROCATHETER. THE NEXT COIL HAD THE SAME RESULT. THE COIL WAS PLACED IN THE INTENDED PLACE. OTHER COILS WERE PLACED IN THE SITE TO FINISH THE CASE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603677 ↗