AZUR 45-880060Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00842429118085), received between Mar 2, 2024 and Aug 11, 2026 — classified as 9 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211662 ↗
• InjuryAug 6, 2026Material Fragmentation; Difficult to Remove; Unraveled Material; Premature Separation

  Patient problems: Vascular Dissection

  MAUDE report 50165459 ↗
• MalfunctionApr 22, 2026Premature Separation

  IT WAS REPORTED DURING AN ANGIOGRAM PROCEDURE, THE PHYSICIAN HAD ALREADY DEPLOYED A FRAMING COIL WHEN THE DETACHMENT CONTROLLER DISPLAYED THREE GREEN BLINKING LIGHTS. HOWEVER, THE COIL DID NOT DETACH AND WAS PULLED BACK INTO THE MICROCATHETER, WHERE IT BECAME CAUGHT ON THE PUSHER WIRE. THEY WERE EVENTUALLY ABLE TO FREE IT BY ¿WIGGLING¿ THE COIL OFF THE PUSHER WIRE, THOUGH IT IS UNKNOWN EXACTLY HOW THE COIL DETACHED. DURING THIS PROCESS, THE COIL BECAME HUNG UP IN THE MICROCATHETER, BUT THEY WERE ABLE TO ADVANCE IT AND PERFORM COILING WITHIN THE ANEURYSM USING A COIL PUSHER. THE COIL WAS SUCCESSFULLY IMPLANTED IN THE INTENDED LOCATION. THERE WAS NO PATIENT INJURY REPORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961136 ↗
• InjuryDec 4, 2025Premature Separation; Premature Separation

  AS REPORTED, THE PHYSICIAN WAS PERFORMING AN ENDOLEAK EMBO. A 2.8 X150CM PROGREAT IN PLACE. AN ATTEMPT TO DELIVER A 60CM HYDROPACK. IT WASN'T FORMING AS DESIRED AND WANTED TO PULLED BACK LIGHTLY TO REPOSITION. FELT IT POP WHEN THE DEVICE WAS PULLED BACK AND REALIZED THE COIL HAD DETACHED. THE PHYSICIAN ENDED UP HAVING TO PULL OUT THE WHOLE SYSTEM AND NOW HAS TO BRING THE PATIENT BACK ANOTHER DAY TO REPEAT PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719554 ↗
• InjuryDec 3, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS DEPLOYED IN A SVG GRAFT THROUGH A MICROCATHETER. THE COIL BECAME DISLODGED AND DETACHED INSIDE THE CATHETER. THE PHYSICIAN REMOVED THE CATHETER AND THE COIL STAYED IN PLACE. MULTIPLE ATTEMPTS TO SNARE THE COIL WERE MADE, WHICH WAS SUCCESSFUL. THE COIL WAS REMOVED, THE GUIDE CATHETER WAS REMOVED. A NEW GUIDE WAS PLACED, A NEW MICROCATHETER WAS PLACED, AND MORE COILS WERE DEPLOYED WITH NO ISSUES. PATIENT WAS STABLE AND DISCHARGED NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711822 ↗
• InjuryOct 30, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23432606 ↗
• MalfunctionAug 6, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT A PERIPHERAL COIL DEVICE WAS USED IN AN UNSPECIFIED PROCEDURE. THE COIL DETACHED IN THE MICROCATHETER AND WAS REMOVED. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733714 ↗
• MalfunctionJul 8, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING UNSPECIFIED ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE COIL IMPLANT THROUGH THE MICROCATHETER AND WAS ABLE TO GET THE COIL OUT OF THE MICROCATHETER ABOUT 70% OF THE 60CM COIL LENGTH. THE PHYSICIAN THEN REALIZED THEY DID NOT HAVE ENOUGH ARTERY LENGTH AND ATTEMPTED TO PULL AND RE-CAPTURE THE COIL BACK INTO THE MICROCATHETER, WHEN THE COIL UNINTENTIONALLY DETACHED. THE COIL WAS IMPLANTED IN THE PATIENT AND CASE COMPLETED AS NORMAL. THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440319 ↗
• InjuryJun 16, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE PHYSICIAN WAS COILING A COLLATERAL, TORTUOUS ANATOMY, THE COIL SPACED OUT A LITTLE SO THEY TRIED TO RECAPTURE THE COIL AND IT STARTED TO UNRAVEL. THEY HAD TO GET A SECOND ACCESS, AND THEY SNARED THE COIL THROUGH A 5FR SHEATH AND IT CAME OUT EASILY. THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED BY THE USER/FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213849 ↗
• MalfunctionMar 10, 2025Premature Separation; Premature Separation

  NO NEW INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556635 ↗
• MalfunctionNov 13, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE HYDROPACK WOULD NOT DETACH WITH THE CONTROLLER. THE CONTROLLER DETACHED 2 OTHER COILS PRIOR TO THE HYDROPACK. THE HYDROPACK THE CONTROLLER SHOWED A GREEN LIGHT AND THE WENT TO RED WHEN THE BUTTON WAS PRESSED. SEVERAL ATTEMPTS WERE MADE AFTER THE GOLD PORTION OF THE WIRE WAS CLEANED. WHEN THE COIL WAS RETRACTED IT DETACHED IN THE MICROCATHETER. THE EVENT DID NOT RESULT IN PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671217 ↗
• MalfunctionOct 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN ANGIOGRAM WITH INTERVENTION. WHEN TRYING TO DEPLOY THE 60CM HYDROPACK, IT BECAME DETACHED FROM THE PUSHER WIRE WHILE IN THE MICROCATHETER. THE MICROCATHETER AND COIL WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS A SUCCESS, AND THE PATIENT REMAINED STABLE THROUGHOUT. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509468 ↗
• MalfunctionSep 12, 2024Premature Separation; Premature Separation

  AS REPORTED, THE 60CM HYDROPACK DETACHED PREMATURELY INSIDE THE 2.4 PROGREAT. THE PHYSICIAN WAS ABLE TO PUSH THE COIL THE REST OF THE WAY OUT OF THE PROGREAT AND SUCCESSFULLY INTO THE VESSEL. PROCEDURE, GI BLEED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208557 ↗
• InjuryAug 7, 2024Material Separation; Migration; Material Separation; Migration

  AS REPORTED: WHILE COILING AN ANEURYSM OFF THE SMA, DR. HAD DELIVERED A 16X39 CX, 14X34 CX AND ONE 60CM HYDROPACK. AS HE WAS DELIVERING THIS 60CM HYDROPACK, HE DETERMINED IT WAS TOO LONG. AS HE WAS REMOVING IT THROUGH THE MICROCATHETER, THE COIL BROKE AT THE TRANSITION POINT WITH THE PUSHER WIRE. APPROXIMATELY 15CM WAS TRAILING DOWN THE SMA. HE SNARED THE WIRE AND AS HE WAS BRINGING IT BACK INTO THE MICROCATHETER, A PORTION OF THE COIL BROKE OFF AND WENT DISTAL INTO A GASTRIC BRANCH. IT APPEARS THERE IS A FILAMENT OF THE WIRE CONNECTING THE REMAINING COIL AND THE DISTAL END. THE PATIENT IS GOING TO SURGERY THE NEXT DAY TO ATTEMPT TO REMOVE THE COIL FROM THE SMA. THE PHYSICIAN USED THE 60CM LENGTH BASED ON RECOMMENDATION. DR. ON SURGERY: HE PERFORMED AN OPEN PROCEDURE TO REMOVE ALL THE COILS (SUCCESSFULLY) AND REPAIRED THE SMA ANEURYSM. PATIENT WAS STABLE. THE FOUR COILS WERE REMOVED AS A PACK DURING AN OPEN SURGERY. THE SURGEON, RESIDENT AND STUDENT PULLED AND STRETCHED THE COILS AS THEY WERE LOOKING AT THEM. THEY ALSO PLACED THEM IN A PATHOLOGY CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Reduced Blood Flow

  MAUDE report 19930964 ↗
• InjuryJul 9, 2024Difficult to Remove; Unraveled Material; Positioning Problem; Difficult to Remove; Unraveled Material; Positioning Problem

  IT WAS REPORTED THAT THE PERIPHERAL EMBOLIZATION COIL WAS USED TO EMBOLIZE A PSEUDOANEURYSM OFF OF THE INFERIOR MESENTERIC ARTERY (IMA). THE COIL WAS THE FIRST COIL USED. A 4F BASE CATHETER AND A 2.8F MICROCATHETER WERE USED. THE PHYSICIAN PUSHED THE 2.8F MICROCATHETER OUT PASSED THE BASE CATHETER RIGHT BEFORE THE ANEURYSM AND THEN ADVANCED THE COIL THROUGH THE 2.8F CATHETER. THE COIL WAS COMING OUT PAST THE ANEURYSM, WHICH THE PHYSICIAN WAS OKAY WITH AS WAS INTENDING TO OCCLUDE THE VESSEL PASSED THE ANEURYSM. THIS SPACE WAS SUB 2MM AND THE COIL WAS PACKING IN SOME AREAS OF THE VESSEL NICELY. THE COIL DID NOT SEEM TO WANT TO PACK IN THE ANEURYSM AS THE PHYSICIAN CONTINUED PUSHING OUT THE COIL. THE PHYSICIAN THEN FELT RESISTANCE AND TRIED TO PULL BACK ON THE COIL AND FELT RESISTANCE AGAIN. COULD NOT MOVE THE COIL FORWARD TO BACKWARD AT THIS POINT. THE PHYSICIAN THEN PULLED THE COIL WITH MORE FORCE THAN FELT WAS NORMAL, HOPING TO REMOVE THE COIL. AT THIS POINT, WAS PULLING BUT THE COIL THAT WAS PACKED PAST THE ANEURYSM WAS NOT MOVING. THE COIL AT THIS POINT WAS UNRAVELING AS PHYSICIAN WAS TRYING TO PULL IT OUT. THE PATIENT WAS THEN SENT TO THE OR TO HAVE THE REST OF THE COIL SURGICAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705825 ↗
• MalfunctionJun 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A GI BLEED TREATMENT, THE COIL HAD RESISTANCE DURING ADVANCEMENT. THE RESISTANCE WAS SIGNIFICANTLY NOTED AS THE COIL TRAVERSED THE ORIGIN OF THE CELIAC. THE HYDROPACK WAS THEN ATTEMPTED TO BE REMOVED AS THE TIP OF THE COIL WITHIN THE CATHETER APPROACHED THE GDA. THE COIL WAS RETRACTED APPROXIMATELY 10CM AND THEN PREMATURELY DETACHED INSIDE THE CATHETER. BOTH THE COIL AND CATHETER WERE SUCCESSFULLY REMOVED. A NEW CATHETER AND COILS WERE USED TO TREAT THE REMAINDER OF THE GDA. THERE WAS NO INTERVENTION OR PATIENT INJURY REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591044 ↗
• MalfunctionJun 21, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED FOR TREATMENT OF A GASTROINTESTINAL (GI) BLEED. A 4FR CATHETER WAS POSITIONED IN THE COMMON HEPATIC ARTERY AND A 2.4FR CATHETER WAS COAXIALLY DELIVERED INTO THE DISTAL GASTRODUODENAL (GDA) ARTERY. PROCEEDING THE PLACEMENT OF 3 COILS, RESISTANCE WAS FELT DURING ADVANCEMENT OF THE CONCERNED COIL. THIS RESISTANCE WAS SIGNIFICANTLY NOTED AS THE COIL TRAVERSED THE ORIGIN OF THE CELIAC. IT WAS THEN DECIDED TO REMOVE THE CONCERNED COIL AS THE TIP OF THE COIL APPROACHED THE GDA (ALL WITHIN THE 2.4FR CATHETER). THE PHYSICIAN WAS ABLE TO RETRACT IT APPROXIMATELY 10CM WHEN THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED AND CASE COMPLETED WITH A NEW MICROCATHETER AND COILS TO TREAT THE REMAINDER OF THE GDA. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587355 ↗
• MalfunctionMay 1, 2024Premature Separation; Premature Separation

  AS REPORTED: THE PHYSICIAN WAS TRYING TO BRING BACK THE HYDROPACK AND THE FILAMENT APPEARS TO HAVE SNAPPED DETACHING THE COIL BEFORE IT WAS INTENDED TO DETACH. NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ALTHOUGH ADDITIONAL PATIENT AND INCIDENT INFORMATION WAS REQUESTED, THE REPORTER STATED THEY WERE UNABLE TO PROVIDE REQUESTED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226951 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS BEING DELIVERED TO THE TREATMENT SITE WHEN THE CATHETER LOST POSITION. THE COIL WAS RETRACTED AND DETACHED WHILE BEING PULLED OUT OF THE CATHETER. THE ENTIRETY OF THE COIL WAS EASILY REMOVED. THE CATHETER WAS REPOSITIONED AND SEVERAL OTHER COILS WERE SUCCESSFULLY DEPLOYED. THERE WAS NO INTERVENTION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154476 ↗
• MalfunctionMar 5, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION OF THE RIMA DURING A PRE-FONTAN CASE. THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL BACK INTO THE MICROCATHETER, BUT THE COIL DETACHED IN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED COIL BY CLAMPING THE CATHETER AND REMOVING THE SYSTEM. THE PHYSICIAN COMPLETED THE CASE BY USING TWO COILS. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842164 ↗
• InjuryMar 4, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS USED IN A GASTRIC BLEED CASE. THE COIL PROVIDED DIFFICULTY DURING PLACEMENT AND IT WAS DECIDED TO REMOVE IT. THE COIL UNRAVELED AND DID NOT COME OUT WITH THE CATHETER WHEN IT WAS REMOVED. THE DOCTOR THEN USED A SNARE DEVICE TO REMOVE THE REMAINING COIL, THEN PROCEEDED TO FINISH THE COILING WITH ANOTHER COIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824129 ↗
• InjuryMar 2, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL WAS USED FOR TREATMENT FOR A CELIAC ANGIOGRAM. DURING POSITIONING AND MANIPULATION WITH THE CATHETER THE COIL UNINTENTIONALLY DETACHED. THE COIL WAS REMOVED USING A SNARE DEVICE. THERE WERE NO ADVERSE EVENTS WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823435 ↗