Azur CX DetachableRecalls & reported problems across all models

We found 22 models of Azur CX Detachable by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 509 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2016 and Sep 25, 2026 — classified as 122 injuries, 387 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (212 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Azur CX Detachable recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 24, 2023Open, Classified

   Peripheral coil system detachable has a potential of unsealed pouch packaging.

   Z-0187-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported Azur CX Detachable problems

Azur CX Detachable models

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

• Azur CX Detachable 45-750824

  Device, Vascular, for Promoting Embolization
  115 reports
• Azur CX Detachable 45-751324

  Device, Vascular, for Promoting Embolization
  1 recall42 reports
• Azur CX Detachable 45-750617

  Device, Vascular, for Promoting Embolization
  76 reports
• Azur CX Detachable 45-752039

  Device, Vascular, for Promoting Embolization
  55 reports
• Azur CX Detachable 45-751019

  Device, Vascular, for Promoting Embolization
  44 reports
• Azur CX Detachable 45-780413

  Device, Vascular, for Promoting Embolization
  28 reports
• Azur CX Detachable 45-751632

  Device, Vascular, for Promoting Embolization
  28 reports
• Azur CX Detachable 45-750812

  Device, Vascular, for Promoting Embolization
  18 reports
• Azur CX Detachable 45-781238

  Device, Vascular, for Promoting Embolization
  15 reports
• Azur CX Detachable 45-750609

  Device, Vascular, for Promoting Embolization
  13 reports
• Azur CX Detachable 45-780620

  Device, Vascular, for Promoting Embolization
  10 reports
• Azur CX Detachable 45-750511

  Device, Vascular, for Promoting Embolization
  10 reports
• Azur CX Detachable 45-780516

  Device, Vascular, for Promoting Embolization
  9 reports
• Azur CX Detachable 45-780828

  Device, Vascular, for Promoting Embolization
  9 reports
• Azur CX Detachable 45-782040

  Device, Vascular, for Promoting Embolization
  9 reports
• Azur CX Detachable 45-781032

  Device, Vascular, for Promoting Embolization
  8 reports
• Azur CX Detachable 45-780724

  Device, Vascular, for Promoting Embolization
  6 reports
• Azur CX Detachable 45-750407

  Device, Vascular, for Promoting Embolization
  5 reports
• Azur CX Detachable 45-781639

  Device, Vascular, for Promoting Embolization
  4 reports
• Azur CX Detachable 45-781434

  Device, Vascular, for Promoting Embolization
  3 reports
• Azur CX Detachable 45-780928

  Device, Vascular, for Promoting Embolization
  1 report
• Azur CX Detachable 45-781836

  Device, Vascular, for Promoting Embolization
  1 report

Recent Azur CX Detachable adverse event reports

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

• InjurySep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906071 ↗
• MalfunctionSep 24, 2026Premature Separation

  As reported: The coil detached from the wire inside the support catheter. The coil and catheter could not be used anymore. No patient injury.Additional information: The coil was removed by retracting the catheter. Also when "[physician]" wanted to pick up the failed coil, it was not available. Only the catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884958 ↗
• MalfunctionSep 15, 2026Premature Separation

  As reported, during a pelvic congestion embolization in an 8mm vessel, an embolization coil implant, reported on a separate report, deployed prematurely in the glidecath and did not advance from the catheter into the vessel. The catheter was removed from the patient and the coil was pulled from the catheter outside of the body. The catheter was reintroduced and this device, a 16mm 0.035 cx coil, was opened. The same premature deployment occurred with this coil. The catheter was removed and the second coil was pulled from the catheter outside of the body. At this point the catheter was replaced with a different glidecath and the procedure continued. all coils delivered with no issues before this event and all further coils used after the catheter was replaced also delivered with no issues. The patient was not harmed. procedure was successful. patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766757 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MICROVENTION: SUCCESSFUL COIL EMBOLIZATION OF OVARIAN VEIN UTILIZING QTY 13- 0.035" CX COILS ON FRIDAY (B)(6) 2026. POST PROCEDURE, PATIENT PRESENTED WITH DIFFUSE RASH ON MONDAY (B)(6) 2026 AND PHYSICIAN CLAIMED THAT THE RASH WAS AN ALLERGIC REACTION TO THE COILS. DOCTOR PRESCRIBED MEDROL DOSEPACK ON MONDAY (B)(6) 2026. THE PATIENT CLAIMED NO METAL ALLERGY. THE PATIENT ALSO HAD A VENOGRAM A WEEK PRIOR TO COIL EMBOLIZATION AND DID NOT HAVE A REACTION POST-PROCEDURE. NO OTHER EMBOLICS USED, NO GEL FOAM, NO SCLEROTHERAPY. QUANTITY OF 13 TOTAL 0.035" CX COILS USED. DEVICE REMAINS IMPLANTED. NO OTHER INCIDENT INFORMATION WAS PROVIDED. AS THE RELATIONSHIP OF THE DEVICE TO THE REPORTED CONDITION COULD NOT DEFINITIVELY BE RULED OUT, THIS EVENT IS BEING REPORTED.

  Patient problems: Rash

  MAUDE report 25667988 ↗
• MalfunctionJun 17, 2026Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS BEING USED IN A GDA EMBOLIZATION PROCEDURE. REPORTEDLY DURING ADVANCING THE COIL IN THE MICROCATHETER, THE COIL PREMATURELY DETACHED PRIOR TO PLACEMENT IN INTENDED SITE. IT WAS UNKNOWN WHETHER THE COILS DETACHED AT THE HUB OR MORE DISTAL IN THE MICROCATHETER. THE SAME NON-TERUMO NEURO CATHETER WAS USED WITH ALL THREE COILS. THE COIL AND CATHETER WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL AT THE END OF THE PROCEDURE. THIS IS EVENT REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540864 ↗
• MalfunctionJun 17, 2026Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS BEING USED IN A GDA EMBOLIZATION PROCEDURE. REPORTEDLY DURING ADVANCING THE COIL IN THE MICROCATHETER, THE COIL PREMATURELY DETACHED PRIOR TO PLACEMENT IN INTENDED SITE. IT WAS UNKNOWN WHETHER THE COILS DETACHED AT THE HUB OR MORE DISTAL IN THE MICROCATHETER. THE SAME NON TERUMO NEURO CATHETER WAS USED WITH ALL THREE COILS. THE COIL AND CATHETER WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL AT THE END OF THE PROCEDURE. THIS IS EVENT REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540853 ↗
• MalfunctionJun 6, 2026Stretched; Premature Separation

  AS REPORTED: DURING ADVANCEMENT OF THE COIL THROUGH A PROGREAT MICROCATHETER, RESISTANCE WAS ENCOUNTERED. THE DOCTOR ATTEMPTED TO REMOVE THE COIL, BUT IT DETACHED WITHIN THE PROGREAT. THE DOCTOR THEN FLUSHED THE COIL TO THE DESIRED TARGET LOCATION AND REMOVED THE DELIVERY WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THIS REPORT ADDRESSES THE SECOND COIL. THE FIRST COIL IS REFERENCED UNDER MFR REPORT #2032493-2026-00365.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418359 ↗
• MalfunctionJun 6, 2026Stretched; Premature Separation

  AS REPORTED: RESISTANCE WAS FELT WHEN ADVANCING THE COIL THROUGH THE GLIDE CATHETER. THE DOCTOR TRIED TO PULL THE COIL BACK OUT OF THE CATHETER, BUT IT STRETCHED AND DETACHED FROM THE CATHETER. THE WHOLE CATHETER WAS REMOVED WITH THE COIL INSIDE. A NEW COIL WAS USED WITHOUT FURTHER ISSUES. THE SAMPLE IS NOT AVAILABLE AND WAS DISCARDED BY THE CUSTOMER. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THIS REPORT ADDRESSES THE FIRST COIL. THE SECOND COIL WILL BE REPORTED IN A SEPARATE SUBMISSION THAT REFERENCES A DIFFERENT MFR REPORT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418348 ↗
• InjuryJun 5, 2026Migration or Expulsion of Device

  THE COMPANY RECENTLY RECEIVED A LEGAL CLAIM LETTER DATED APRIL 28, 2026, REPORTING, FOR THE FIRST TIME, POST-OPERATIVE INJURIES THAT OCCURRED 2 YEARS AFTER ON (B)(6) 2023 EMBOLIZATION PROCEDURE. AS REPORTED, A FEMALE PATIENT UNDERWENT EMBOLIZATION FOR PELVIC VENOUS INSUFFICIENCY USING SEVERAL AZUR® CX DETACHABLE COILS MANUFACTURED BY TERUMO MEDICAL/MICROVENTION. TWO YEARS AFTER THE COILS WERE IMPLANTED IN THE LEFT OVARIAN VEIN, IT WAS REPORTED THAT ONE OR MORE MIGRATED TO THE PULMONARY CIRCULATION, SPECIFICALLY LODGING IN THE LEFT LOWER LOBE OF THE LUNG. THIS MIGRATION LED TO PULMONARY SYMPTOMS AND COMPLICATIONS, REQUIRING THE PATIENT TO BE HOSPITALIZED AND UNDERGO BOTH ANTICOAGULATION THERAPY AND AT LEAST ONE SURGICAL OR ENDOVASCULAR INTERVENTION ON (B)(6) 2025. THE OUTCOME IS CONSIDERED A SERIOUS INJURY, WITH SIGNIFICANT MEDICAL INTERVENTION AND ONGOING HEALTH IMPACTS. THE DEVICES INVOLVED ARE MULTIPLE AZUR® CX DETACHABLE COILS (VARIOUS SIZES AND CATALOG NUMBERS), WHICH ARE DESIGNED FOR VASCULAR OCCLUSION PROCEDURES. THE ISSUE REPORTED IS MIGRATION OF THE COIL(S) AFTER PROPER IMPLANTATION¿THERE IS NO ALLEGATION OF DEVICE BREAKAGE OR DETACHMENT FAILURE BEFORE DEPLOYMENT. THE PRIMA

  Patient problems: Pulmonary Embolism

  MAUDE report 25411333 ↗
• MalfunctionJun 4, 2026Premature Separation

  AS REPORTED, THE COIL WAS DELIVERED THROUGH THE CATHETER; HOWEVER, THE COIL DETACHED PREMATURELY WITHIN THE CATHETER. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT. A NEW COIL WAS OPENED, AND THE SAME CATHETER WAS REPOSITIONED INTO THE INTERNAL ILIAC OUTFLOW ARTERY. THE NEW COIL WAS DEPLOYED WITHOUT ISSUE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402688 ↗
• MalfunctionJun 2, 2026Premature Separation

  AS REPORTED: CARTO PROCEDURE STARTED WITH LARGE 0.035 COILS WHICH WERE SUCCESSFULLY DEPLOYED WITH NO PROBLEMS THROUGH THE BASE CATHETER. OPERATOR BEGAN TO STEP DOWN IN SIZE WHEN THE 16X32 0.035 CX IN QUESTION WAS PULLED. PREP OF THE COIL WAS PERFORMED WITH NO ISSUES, BASE CATHETER WAS FLUSHED AND COIL WAS INSERTED INTO BASE CATHETER. THE COIL WAS TRACKING ADEQUATELY THROUGH THE TORTUOUS ANATOMY UNTIL RESISTANCE WAS MET. AFTER MANIPULATING THE COIL AND SEVERAL ATTEMPTS TO ADVANCE THE COIL, IT APPEARED TO DETACH FROM THE PUSHER WIRE. OPERATOR REMOVED THE CATHETER ENTIRELY TO SAFELY REMOVE THE COIL. NO HARM TO THE PATIENT, NEW BASE CATHETER WAS ADVANCED, AND COILING RESUMED WITH NO FURTHER ISSUES. DID NOT RECOVER THE COIL AS IT WAS LODGED INSIDE THE BASE CATHETER. OVERALL CASE WAS SUCCESSFUL AND OPERATOR WAS VERY PLEASED WITH THE OUTCOME. COIL IN QUESTION NEVER LEFT THE CATHETER HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366028 ↗
• MalfunctionMay 28, 2026Component Missing

  IT WAS REPORTED THAT BY THE PHYSICIAN THAT WHILE PERFORMING A VARICOCELE EMBOLIZATION, SHE CHOSE AN AZUR COIL IMPLANT, PREPPED NORMALLY AND SHE INTRODUCED COIL CASING TO HUB OF CATHETER AND STARTED ADVANCING THE PUSHER WIRE. THE PHYSICIAN REMOVED THE CASING, AND SHE HIT THE FLUORO PEDAL AND CONTINUED TO ADVANCE THE COIL. SHE THEN NOTICED THAT THE COIL PACK STARTED TO MOVE BUT SHE DIDN'T SEE ANY COIL. SHE THEN PULLED BACK AND NOTICED THAT THERE WAS NO COIL ON THE END OF THE PUSHER WIRE. SHE SPENDS A FAIR BIT OF TIME ENSURING THE COIL HAD NOT DETACHED ANYWHERE IN HER SYSTEM. IT WAS THEN ASSUMED THAT NO COIL WAS EVER PRESENT ON THE PUSHER WIRE. THE PATIENT OUTCOME IS CURRENTLY UNKNOWN, AND TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321231 ↗
• MalfunctionMay 11, 2026Physical Resistance/Sticking; Premature Separation

  AS REPORTED, THE AZUR CX 18 DETACHABLE COIL FELT SMOOTH WHEN PUSHED UP TO TIP OF THE PROGREAT MICRO CATHETER BUT COULD NOT PUSH IT FURTHER DESPITE USING A NEW PROGREAT MICRO CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED: TIP OF THE AZUR CX 18 DETACHABLE COIL WENT ALL THE WAY TO THE TIP OF THE PROGREAT MICRO CATHETER HOWEVER, THIS DETACHED FROM DELIVERY WIRE AND THE USER WAS ABLE TO FLUSH IT INTO THE ANEURYSM WITH NO ISSUE. THERE WAS A TIGHT CO-ILIAC TRUNK STENOSIS TO GET THROUGH BEFORE GOING INTO THE GDA. IT WAS INDICATED THAT THIS MAY HAVE CONTRIBUTED. THERE WAS NO ISSUE FOR THE PATIENT AND THE COIL REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143905 ↗
• InjuryMay 7, 2026Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119649 ↗
• MalfunctionMay 7, 2026Premature Separation

  IT WAS REPORTED THAT DURING AN INTERNAL ILIAC EMBOLIZATION CASE, THE COIL GOT STUCK WHEN THEY WERE PUSHING THE COIL THOUGH THE CATHETER. WHEN THEY PULLED THE COIL BACK OUT OF THE CATHETER IT DETACHED. THIS WAS THE FIRST COIL. ALL THE OTHER COILS WORKED CORRECTLY & THE CASE FINISHED SUCCESSFULLY. PATIENT LEFT THE ROOM IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113540 ↗

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