AZURRecalls & reported problems across all models

We found 14 models of AZUR by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 104 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2017 and Sep 25, 2026 — classified as 44 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (75 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 problems

AZUR models

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

• AZUR 45-880060

  Device, Vascular, for Promoting Embolization
  22 reports
• AZUR 45-880035

  Device, Vascular, for Promoting Embolization
  21 reports
• AZUR 45-880020

  Device, Vascular, for Promoting Embolization
  12 reports
• AZUR 45-780204-L

  Device, Vascular, for Promoting Embolization
  9 reports
• AZUR 45-880010

  Device, Vascular, for Promoting Embolization
  9 reports
• AZUR 45-880050

  Device, Vascular, for Promoting Embolization
  9 reports
• AZUR 45-780308-L

  Device, Vascular, for Promoting Embolization
  8 reports
• AZUR 45-780202-L

  Device, Vascular, for Promoting Embolization
  5 reports
• AZUR 45-780304-L

  Device, Vascular, for Promoting Embolization
  4 reports
• AZUR 45-880005

  Device, Vascular, for Promoting Embolization
  1 report
• Azur 45-780204-02

  Device, Vascular, for Promoting Embolization
  1 report
• Azur 45-780308-02

  Device, Vascular, for Promoting Embolization
  1 report
• Azur 45-780516-02

  Device, Vascular, for Promoting Embolization
  1 report
• AZUR 45-682050-02

  Device, Vascular, for Promoting Embolization
  1 report

Recent AZUR adverse event reports

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

• MalfunctionSep 25, 2026Premature Separation

  As reported, the Hydropack detached inside the microcatheter. The microcatheter was changed, and a competitor device was used to complete the procedure. Additional information received indicated that each device was removed along with the microcatheter. The procedure was successful and there was no patient impact reported. The Hydropacks are not available because the account discarded them.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900100 ↗
• MalfunctionSep 25, 2026Premature Separation

  As reported, the Hydropack detached inside the microcatheter. Additional information received indicated that each device was removed along with the microcatheter. The case was completed by changing the microcatheter and using competitor coils. The procedure was successful. There was no patient impact reported. The Hydropacks are not available because the account discarded them.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899912 ↗
• MalfunctionSep 24, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890537 ↗
• 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 ↗
• InjuryAug 20, 2026Premature Separation

  As reported during a Visceral embolization, the AZUR Hydropack coil implant was introduced in an embolization procedure. During the procedure, the Hydropack coil was inserted into a Progreat microcatheter and advanced to the target vessel for deployment. The physician tried retracting the coil back into the microcatheter, but the coil prematurely detached. Because of the premature detachment, the coil was left in an undesirable position, so it was necessary to remove it with a snare. The coil was successfully removed with the snare. The patient outcome had no complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356255 ↗
• 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 ↗
• InjuryJul 16, 2026Premature Separation

  IT WAS REPORTED THAT DURING A VASCULAR EMBOLIZATION, THE PRACTITIONER USED AN EMBOLIZATION COIL IMPLANT THAT RELEASED UNEXPECTEDLY INSIDE THE PATIENT, WITHOUT ACTIVATION OF THE DETACHMENT SYSTEM. IT WAS SUBSEQUENTLY RETRIEVED USING A SNARE. CONSEQUENTLY, ANOTHER COIL OF THE SAME REFERENCE AND LOT NUMBER WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS ALSO REPORTED TO BE AN INCREASE IN OPERATING TIME OF APPROXIMATELY 45 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850690 ↗
• MalfunctionJun 26, 2026Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY. THE COIL WAS IN SATISFACTORY POSITION; THERE WERE NO COMPLICATIONS AND THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642002 ↗
• InjuryJun 12, 2026Failure to Advance

  AS REPORTED: DURING TRANS-CAVAL EMBO PROCEDURE, A 018 X 150 CM CATHETER WAS ABLE TO CROSS THE AORTIC SAC, NO OTHER CATHETER WAS ABLE TO CROSS. ONCE THE CATHETER REACHED WHERE IT NEEDED TO BE, THE CATHETER WAS FLUSHED AND LOADED WITH THE 35 CM HYDROPACK. THERE WERE NO ISSUES UNTIL THE COIL REACHED THE TIP OF THE CATHETER, SO THE CATHETER WAS PULLED BACK SLIGHTLY. THE COIL WAS STILL UNABLE TO BE PUSHED OUT. WHILE PULING THE COIL OUT, THE PUSHER WIRE APPEARED DETACHED FROM THE COIL. AN ATTEMPT TO FLUSH IN THE COIL WAS WITHOUT SUCCESS. AN ATTEMPT TO PUSH THE COIL IN WITH A WIRE WAS WITHOUT SUCCESS. THE CATHETER WAS PULLED OUT WITH THE COIL INSIDE AND ACCESS TO THE SAC WAS LOST DUE TO THIS ISSUE. THE CASE WAS THEN CALLED DUE TO THE AMOUNT OF TIME IT TOOK TO GET THE CATHETER INTO POSITION AND THEN LOSING ACCESS. THE COIL WAS STRUNG OUT AND PULLED FROM THE CATHETER. THE PATIENT¿S ANEURYSM WAS LEFT UNTREATED WHEN THE PROCEDURE WAS CALLED. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION. THE PATIENT WAS PLANNED TO BE DISCHARGED AND GO HOME ON THE SAME DAY AS THE PROCEDURE. THE PLAN IS TO HAVE THE PATIENT GET AN ADDITIONAL CT IN 3 MONTHS TO SEE IF THE ANEURYSM SAC IS STILL GROWING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488431 ↗
• InjuryMay 31, 2026Unraveled Material

  IT WAS REPORTED THAT DURING A LUMBAR BLEED EMBOLIZATION PROCEDURE, COILS WERE SUCCESSFULLY DEPLOYED TO CREATE AN ADEQUATE PACK. THE PARENT CATHETER WAS JAMMED IN THE PACK AND WHEN REMOVED, IT PULLED A PORTION OF THE COIL INTO THE AORTA. THE PHYSICIAN THEN USED A SNARE TO RETRIEVE THE COIL SUCCESSFULLY. THE COIL WAS OBSERVED TO BE UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344985 ↗
• MalfunctionMay 29, 2026Premature Separation

  IT WAS REPORTED THAT CUSTOMER STATES COIL DETACHED WITHOUT PROPERLY USING PICKLE. THE DEVICE IMPLANTED AND DETACHED SAFELY INTO THE PATIENT. NO COMPLICATIONS AND PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340362 ↗
• InjuryMay 21, 2026Premature Separation

  IT WAS REPORTED THAT DURING AN ENDO LEAK PROCEDURE, THE COIL WAS MANIPULATED A LOT IN THE ARTERY, AND IT BROKE OFF THE PUSHER WIRE. THE DOCTOR HAD TO USE A SNARE TO REMOVE IT FROM THE ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244209 ↗
• MalfunctionMay 4, 2026Premature Activation; Premature Separation

  IT WAS REPORTED THAT GDA EMBOLIZATION. A FEMORAL ACCESS VIA 6F SHEATH, 5F BASE CATHETER USED AND A 2.4FX110CM PROGREAT AND 016 GWGT TO ACCESS CELIAC TO GDA. SOME KICKBACK WAS OBSERVED WITH CATHETER MAINTAINING SUPPORT INTO THE CELIAC TRUNK THROUGHOUT THE CASE. DEPLOYED TWO 018CX COILS FIRST TO CREATE A BACK STOP AND HAD NO ISSUES. DEPLOYED A 10CM HYDROPACK WITH NO ISSUE. WENT TO DEPLOY THE SECOND 10CM HYDROPACK AND THE BLACK STOPPER GOT STUCK IN THE HOOP AND CAUSED THE COIL INTRODUCER SHEATH TO STAY IN THE HOOP. WHEN THE TECH WAS FINALLY ABLE TO GET THE COIL OUT OF THE HOOP, THE TECH FELT SOME RESISTANCE. THE PHYSICIAN AND I BOTH EXAMINED THE COIL ON THE BACK TABLE AND DECIDED NOT TO USE IN THE PATIENT BECAUSE WE WERE CONCERNED ABOUT POTENTIAL STRETCHING TO THE CONNECTION POLYMER AND THE COIL BODY ITSELF. A SECOND 10CM HYDROPACK WAS PULLED. NO ISSUES REMOVING FROM THE HOOP. AS THE PHYSICIAN WAS ADVANCING THIS HYDROPACK THROUGH THE PROGREAT IT SELF-DETACHED. THE PHYSICIAN WAS ABLE TO CONTAIN IT WITHIN THE PROGREAT, REMOVE THE MICROCATHETER ENTIRELY FROM THE BODY AND SAFELY REMOVE THE COIL FROM THE MICROCATHETER. UNFORTUNATELY, THE COIL WAS HANGING OUT OF THE PROGREAT SLIGHTLY AND EN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075363 ↗
• 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 ↗

Other Microvention, Inc. products

• Azur CX Detachable22 models · 509 reports · 1 recall
• Stent63 models · 237 reports · 2 recalls
• Azur Detachable Helical HydroCoil42 models · 190 reports
• V-Trak75 models · 147 reports
• WEB14 models · 134 reports
• HydroSoft 3D26 models · 101 reports
• MicroPlex Helical Soft9 models · 8 reports · 1 recall
• ERIC Retrieval Device3 models · 5 reports · 1 recall