Azur Detachable Helical HydroCoilRecalls & reported problems across all models

We found 42 models of Azur Detachable Helical HydroCoil by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2016 and Sep 30, 2026 — classified as 1 death, 41 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (90 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Azur Detachable Helical HydroCoil problems

Azur Detachable Helical HydroCoil models

42 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Azur Detachable Helical HydroCoil 45-480420

  Device, Vascular, for Promoting Embolization
  19 reports
• Azur Detachable Helical HydroCoil 45-480410

  Device, Neurovascular Embolization
  14 reports
• Azur Detachable Helical HydroCoil 45-452030

  Device, Vascular, for Promoting Embolization
  10 reports
• Azur Detachable Helical HydroCoil 45-451230

  Device, Vascular, for Promoting Embolization
  9 reports
• Azur Detachable Helical HydroCoil 45-450820

  Device, Vascular, for Promoting Embolization
  8 reports
• Azur Detachable Helical HydroCoil 45-480202

  Device, Neurovascular Embolization
  8 reports
• Azur Detachable Helical HydroCoil 45-480305

  Device, Vascular, for Promoting Embolization
  8 reports
• Azur Detachable Helical HydroCoil 45-480620

  Device, Vascular, for Promoting Embolization
  8 reports
• Azur Detachable Helical HydroCoil 45-450620

  Device, Vascular, for Promoting Embolization
  7 reports
• Azur Detachable Helical HydroCoil 45-451530

  Device, Vascular, for Promoting Embolization
  7 reports
• Azur Detachable Helical HydroCoil 45-480415

  Device, Vascular, for Promoting Embolization
  7 reports
• Azur Detachable Helical HydroCoil 45-480405

  Device, Vascular, for Promoting Embolization
  5 reports
• Azur Detachable Helical HydroCoil 45-480610

  Device, Neurovascular Embolization
  5 reports
• Azur Detachable Helical HydroCoil 45-480815

  Device, Neurovascular Embolization
  5 reports
• Azur Detachable Helical HydroCoil 45-482030

  Device, Vascular, for Promoting Embolization
  5 reports
• Azur Detachable Helical HydroCoil 45-450815

  Device, Vascular, for Promoting Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-451020

  Device, Vascular, for Promoting Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-451520

  Device, Vascular, for Promoting Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-480615

  Device, Vascular, for Promoting Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-480820

  Device, Neurovascular Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-481015

  Device, Neurovascular Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-481220

  Device, Vascular, for Promoting Embolization
  4 reports
• Azur Detachable Helical HydroCoil 45-480204

  Device, Neurovascular Embolization
  3 reports
• Azur Detachable Helical HydroCoil 45-480310

  Device, Vascular, for Promoting Embolization
  3 reports
• Azur Detachable Helical HydroCoil 45-481020

  Device, Neurovascular Embolization
  3 reports
• Azur Detachable Helical HydroCoil 45-450415

  Device, Vascular, for Promoting Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-450610

  Device, Vascular, for Promoting Embolization
  1 death2 reports
• Azur Detachable Helical HydroCoil 45-451015

  Device, Vascular, for Promoting Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-451220

  Device, Vascular, for Promoting Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-452020

  Device, Vascular, for Promoting Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-481215

  Device, Vascular, for Promoting Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-481520

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Azur Detachable Helical HydroCoil 45-481530

  Device, Vascular, for Promoting Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-480510

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Azur Detachable Helical HydroCoil 45-480515

  Device, Neurovascular Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-480520

  Device, Neurovascular Embolization
  2 reports
• Azur Detachable Helical HydroCoil 45-450410

  Device, Vascular, for Promoting Embolization
  1 report
• Azur Detachable Helical HydroCoil 45-451215

  Device, Vascular, for Promoting Embolization
  1 report
• Azur Detachable Helical HydroCoil 45-480302

  Device, Neurovascular Embolization
  1 report
• Azur Detachable Helical HydroCoil 45-480810

  Device, Neurovascular Embolization
  1 report
• Azur Detachable Helical HydroCoil 45-481010

  Device, Neurovascular Embolization
  1 report
• Azur Detachable Helical HydroCoil 45-481515

  Device, Neurovascular Embolization
  1 report

Recent Azur Detachable Helical HydroCoil adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Separation

  As reported, the patient had an abdominal aortic pseudoaneurysm (diameter: 50 mm). During the procedure, a 5F angiographic catheter was used to deliver the first AZUR 20-30 coil. Significant resistance was encountered during advancement, resulting in separation of the delivery wire from the coil. The angiographic catheter was subsequently withdrawn. A new angiographic catheter was then used, and two AZUR 20-30 coils were successfully delivered without issue. A covered stent was subsequently deployed, and the procedure was completed successfully. The patient returned safely to the ward, and no harm or adverse clinical impact occurred. Patient condition, stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941629 ↗
• MalfunctionJul 15, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830032 ↗
• MalfunctionSep 16, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS USED TO TREAT A PATIENT WITH AN UNRUPTURED ABDOMINAL INTERNAL ILIAC ARTERY ANEURYSM. THE COIL WAS DEPLOYED AS THIRD COIL VIA AN ANGIOGRAPHIC CATHETER WITHOUT THE USE OF A MICROCATHETER. DURING PLACEMENT OF THE THIRD COIL, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. DESPITE REPOSITIONING THE CATHETER, FURTHER ADVANCEMENT REMAINED IMPOSSIBLE. WHILE ATTEMPTING TO WITHDRAW, THE COIL PREMATURELY DETACHMENT IN ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS DISCONTINUED DUE TO THE INABILITY TO COMPLETE EMBOLIZATION. PRIOR TO THE DETACHMENT OF THIS COIL, TWO COILS OF THE SAME MODEL HAD ALREADY BEEN DEPLOYED FOR EMBOLIZATION. ANGIOGRAPHY CONFIRMED THAT THE EMBOLIZATION EFFECT HAD BEEN ACHIEVED AND NO ADDITIONAL COILS WERE IMPLANTED THEREAFTER. THE VASCULAR ANATOMY MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE COIL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065119 ↗
• InjuryAug 15, 2025Premature Separation; Premature Separation

  PLEASE SEE SECTION H11 FOR CORRECTION TO INCLUDE SERIOUS INJURY, AS THE COIL DETACHED WITHOUT USING THE DETACHMENT CONTROLLER BEFORE REACHING THE TARGET SITE AND THEREFORE, EMBOLIZATION OF AN ARTERY OTHER THAN THE ONE INITIALLY INTENDED OCCURRED AS THE COIL WAS LEFT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814999 ↗
• MalfunctionAug 6, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ATTEMPTED DEPLOYMENT OF THE COIL THE COIL DETACHED PREMATURELY WHILE BEING RETRACTED BUT REMAINED INSIDE THE CATHETER. NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729105 ↗
• MalfunctionJul 29, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT A COMPETITOR BASE CATHETER, THEN A 2.4 MICROCATHETER CATHETER WAS USED IN THE CELIAC THEN GDA. PUSHED COIL THROUGH CATHETER, AFTER PLACING 2 COMPETITOR COILS. THE COIL OF CONCERN GOT HUNG UP IN THE CATHETER AND PREMATURELY DETACHED. WAS ABLE TO REVERSE SUCTION COIL PARTWAY INTO THE MICROCATHETER THEN PULL THE MICROCATHETER INTO THE BASE CATHETER AND REVERSE SUCTION AND PULL THE BASE CATHETER OUT WITH THE COIL. NO HARM TO PATIENT. ENDED UP USING GELFOAM EMBOLIC AGENT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22657102 ↗
• InjuryJun 10, 2025Entrapment of Device; Difficult to Remove; Unraveled Material; Difficult or Delayed Separation; Entrapment of Device; Difficult to Remove; Unraveled Material; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A RENAL EMBOLIZATION PROCEDURE, THE COIL UNSUCCESSFULLY DEPLOYED AFTER MULTIPLE (NORMAL) CYCLES WITH CONTROLLER. PHYSICIAN TRIED TO MANUALLY DEPLOY VIA PUSHER WIRE ROTATION. COIL DEPLOYED BUT SUPPORT MICROCATHETER WAS A DISTANCE AWAY FROM THE END OF COIL. UPON DEPLOYMENT RECOIL OF THE ADHESIVE STRIP (CONDUIT FOR THE THERMO / ELECTRIC DISCHARGE THAT IS AFFIXED ON THE WIRE) WRAPPED THE COIL. ADHESIVE STRIP FINALLY DISENGAGED WITH A SMALL TAG END LEFT THAT WAS STILL IN THE TARGET ARTERY. THE PUSHER WIRE WAS DETACHED BUT ROTATION AND WAS REMOVED W/O INCIDENT. NO INTERVENTION WAS USED TO REMOVE THE COIL. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181540 ↗
• MalfunctionMar 28, 2025Premature Separation; Premature Separation

  AS REPORTED IN AN INTERVENTIONAL RADIOLOGY, AN AZUR COIL WAS USED DURING THE PROCEDURE. THE COIL DETACHED SPONTANEOUSLY FROM ITS DELIVERY CATHETER INTO THE MICROCATHETER, WITHOUT MANIPULATION ERROR. THE DEVICE WAS REMOVED, AND A SECOND COIL WAS USED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724168 ↗
• MalfunctionMar 11, 2025Premature Separation; Premature Separation

  ADDITIONAL PATIENT DEMOGRAPHIC INFORMATION RECEIVED IN SECTIONS: A2, A3A, A4. SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21579639 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN IN INTERVENTIONAL RADIOLOGY, THE DEVICE'S RELEASE WIRE BROKE DURING USE, PREVENTING USE OF THE EQUIPMENT WITH THE RELEASE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360458 ↗
• MalfunctionNov 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY. THE IMPLANT WAS REMOVED AND THE CASE WAS COMPLETED WITH ANOTHER IMPLANT COIL. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692156 ↗
• InjuryAug 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A HEPATIC ARTERY EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL PREMATURELY DETACHED WITH HALF OF THE COIL OUTSIDE THE CATHETER. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL IN INTENDED SITE WITH USE OF GUIDEWIRE AND COIL PUSHER WITH NO SUCCESS. THE COIL WAS RETRIEVED BY PUSHING THE 2.5FR MICROCATHETER OVER ABOUT 80% AND THEN PULLED OUT THROUGH THE MOTHER CATHETER WITH ASPIRATION (WITH EVERYTHING CROSSED). THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027189 ↗
• InjuryMay 8, 2024Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Migration; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING TREATMENT OF A GASTRODUODENAL ARTERY (GDA) BLEED, THE THIRD EMBOLIZATION COIL IMPLANT TO BE IMPLANTED WAS NOT TAKING SHAPE IMMEDIATELY AND SO THE MICROCATHETER WAS USED TO COMPACT IT. WHEN ADVANCEMENT OF THE PUSHER WAS RESUMED, IT WAS NOTICED THAT THE IMPLANT HAD DETACHED UNEXPECTEDLY. THE CATHETER WAS FLUSHED WITH SALINE, WHICH MANUALLY PUSHED THE COIL OUT OF IT BUT ALSO CAUSED THE CATHETER TO LOSE POSITION AND BACK UP INTO THE HEPATIC ARTERY. THE IMPLANT COIL WAS THEN REPORTED TO HANGING INTO THE HEPATIC ARTERY, AT WHICH POINT THE BACK HALF OF THE COIL MIGRATED UP AND INTO THE LEFT HEPATIC ARTERY, WHERE IT STARTED TO TAKE ITS HELICAL SHAPE. IT WAS REPORTED TO HAVE A DUMBBELL SHAPE. ONE END OF THE IMPLANT WAS IN THE GDA, THEN IT STRAIGHTENED OUT AND UP INTO THE LEFT HEPATIC ARTERY WHERE THE OTHER END COILED AGAIN. THE GDA WAS OCCLUDED AND ACHIEVED THE RESULT DESIRED BY THE PHYSICIAN REGARDING THE EXISTING GDA BLEED. IT WAS REPORTED THAT, UPON FOLLOW UP, THE PATIENT HAD BEEN CONTINUING TO BLEED AND EXHIBITED SIGNS OF LIVER SHOCK. THE PATIENT LATER PASSED AWAY. IT WAS REPORTED THAT THE PHYSICIAN STATED THAT THE IMPLANT COIL DID NOT CONTRIBUTE TO THE PATIE

  Patient problems: Obstruction/Occlusion

  MAUDE report 19271597 ↗
• MalfunctionApr 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A VENOUS COLLATERAL EMBOLIZATION. AFTER PLACING MULTIPLE COILS, THIS HYDRO COIL WAS SELECTED, WHICH WAS PREPPED AS NORMAL AND WAS INTRODUCED INTO THE MICROCATHETER WITHOUT INCIDENT. AS THE PHYSICIAN WAS DEPLOYING THE COIL, IT GOT STUCK ABOUT 1/3 OF THE WAY OUT OF THE MICROCATHETER. THE PHYSICIAN TRIED TO RETRACT AND THE COIL PREMATURELY DEPLOYED INSIDE THE CATHETER. PHYSICIAN WAITED ABOUT 5-8 MINUTES FOR THE HYDRO TO EXPAND AND TOOK COIL AND MICROCATHETER OUT TOGETHER. THE PHYSICIAN WAS ABLE TO REINTRODUCE THE CATHETER AND FINISHED CASE WITHOUT INCIDENT. THE EMBOLIZATION PROCEDURE WAS SUCCESSFUL WITHOUT REPORT OF HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159192 ↗
• MalfunctionApr 1, 2024Packaging Problem; Packaging Problem

  AS REPORTED: THE REPRESENTATIVE PULLED A HYDROCOIL OUT OF THE BOX PRIOR TO A CASE. THE HYDROCOIL PACKAGE HAD A RED REJECTED STICKER ON THE BACK OF THE COIL PLASTIC PACKING. THERE WAS NO OTHER STICKER OR LABEL NOTED ON THE BOX OR EXTERIOR PACKAGING OF THE COIL. NO OTHER PACKAGES WERE FOUND WITH A SIMILAR STICKER. THE STERILE PLASTIC PACKING WAS INTACT. THE COIL WAS NEVER PRESENTED TO A CUSTOMER OR USED WITH A PATIENT, NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015160 ↗

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