Azur CX Detachable 45-751324Recalls & reported problems
Microvention, Inc. · Azur · Class 2 · Implant
All models of Azur CX Detachable (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Microvention Azur CX detachable coil is an implant used to block off blood vessels by promoting embolization. The 43 reports mostly describe the coil coming loose or detaching too early inside the vessel, sometimes with strands drifting toward the vena cava that had to be caught and removed, along with some sticking during delivery. Six reports describe injuries and there are no deaths. One recall, started in August 2023 and still open, concerns packaging that may not be sealed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00812636021089), received between Apr 20, 2016 and Dec 9, 2025 — classified as 6 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (20 reports).
1 FDA recall record name this device's 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, 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.
Reports received per month
Recalls naming this device
- Aug 24, 2023Class IIOpen, 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 problems
Device problems
- Premature Separation20
- Detachment of Device or Device Component18
- Detachment Of Device Component3
- Device-Device Incompatibility3
- Physical Resistance/Sticking2
- Device Handling Problem1
- Difficult or Delayed Positioning1
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient12
- Aneurysm2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Premature Separation; Premature Separation
NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764577 ↗MalfunctionDec 3, 2025Premature Separation; Premature Separation
NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23702417 ↗InjuryNov 6, 2025Unraveled Material; Migration; Difficult or Delayed Separation; Unraveled Material; Migration; Difficult or Delayed Separation
AS REPORTED, HYPOGASTRIC VEIN EMBOLIZATION WAS PERFORMED WITH AZUR CX. AFTER COIL PLACEMENT AT LOCATION, IT WAS DELIVERED WITH COIL DETACHING SYSTEM. DURING COIL CATHETER REMOVAL, A STRAND WAS OBSERVED HEADING TOWARDS CAVA VEIN. THEY USE A FILTER TO CATCH THE STRAND AND REMOVE IT FROM PATIENT VIA INTRODUCTOR. DURING REMOVAL, THE COIL ALSO STARTED TO MOVE FROM HYPOGASTIC VEIN, SO IT WAS ALSO REMOVED IN THE SAME MOMENT. IT WAS REALIZED THAT THE STRAND AND AZUR CX COIL WERE A SINGLE PIECE. THE COIL DID NOT DETACH PROPERLY DURING DETACHMENT. AS THE COIL WAS REMOVED, THE COIL STRETCHED AT THE JOINT AND BROKE. THE COIL MOVED TOWARDS THE CAVA VEIN FOLLOWING THE BLOOD FLOW. NO PATIENT HARM WAS REPORTED.ADDITIONAL INFORMATION INDICATED, THE ENTIRE COIL WAS REMOVED USING THE FILTER. THE CASE WAS ENDED FOLLOWING REMOVAL OF THE COIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487100 ↗MalfunctionOct 30, 2025Premature Separation; Premature Separation
MalfunctionOct 29, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT COIL PREMATURELY DETACHED IN THE PATIENT DUE TO SIGNIFICANT TORTUOSITY IN THE VESSEL. NO INJURY TO THE PATIENT AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420744 ↗MalfunctionOct 15, 2025Premature Separation; Premature Separation
MalfunctionSep 15, 2025Premature Separation; Premature Separation
NO ADDITIONAL INCIDENT INFORMATION WAS RECEIVED; HOWEVER, THE EVALUATION OF THE RETURNED DEVICE IS COMPLETED. PLEASE SEE H6 & H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053986 ↗InjuryMar 10, 2025Premature Separation; Premature Separation
AS REPORTED: PROVIDER WAS DOING A RENAL ANEURYSM COILING IN HYBRID ROOM USING FLUOROSCOPY AND 2 OF THE AZUR COILS BROKE INTO 2 PIECES WHEN MANIPULATING THEM INTO PLACE. PROVIDER VERBALIZED ALL PIECES OF THE COIL WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567253 ↗InjuryMar 3, 2025Premature Separation; Premature Separation
MalfunctionFeb 9, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation
IT WAS REPORTED THAT DURING A TIPS EMBOLIZATION OF GASTRIC VARICES, AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE IN A 4F CATHETER. THE IMPLANT THEN UNEXPECTEDLY DETACHED INSIDE THE CATHETER. THE ENTIRE CATHETER AND COIL WERE SAFELY REMOVED AND NO HARM WAS CAUSED TO THE PATIENT. THE LEFT GASTRIC VEIN WAS SUCCESSFULLY EMBOLIZED WITH THE 2 COILS PLACED PRIOR TO THE UNEXPECTED COIL DETACHMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341246 ↗MalfunctionOct 17, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS USED TO TREAT A PATIENT WITH A SPLENIC ANEURYSM. REPORTEDLY, DURING DEPLOYMENT, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN USED OTHER COILS FROM DIFFERENT BRAND TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477657 ↗MalfunctionOct 17, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS USED TO TREAT A PATIENT WITH A SPLENIC ANEURYSM. REPORTEDLY, DURING DEPLOYMENT, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN USED OTHER COILS FROM DIFFERENT BRAND TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477579 ↗MalfunctionOct 17, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS USED TO TREAT A PATIENT WITH A SPLENIC ANEURYSM. REPORTEDLY, DURING DEPLOYMENT, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN USED OTHER COILS FROM DIFFERENT BRAND TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477507 ↗MalfunctionOct 4, 2024Premature Separation; Premature Separation
AS REPORTED: THE HOSPITAL STAFF WERE GIVEN THE DEVICE, AND IT WAS NOTED THAT THE COIL DETACHED IN THE BASE CATHETER AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS MARKED AS A MALFUNCTION ONLY AND THERE WAS NO PATIENT IMPACT, INJURY OR INTERVENTION. ALTHOUGH REQUESTED, THE REPORTER HAD NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20372125 ↗MalfunctionSep 17, 2024Difficult or Delayed Positioning; Physical Resistance/Sticking; Premature Separation; Difficult or Delayed Positioning; Physical Resistance/Sticking; Premature Separation
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT HAD TO BE POSITIONED SEVERAL TIMES. THE COIL BECAME STUCK AND WOULD NOT ADVANCE OUT OF THE CATHETER. DURING RETRACTION OF THE COIL, THE COIL BECAME STUCK AND THEN UNEXPECTEDLY DETACHED FROM THE PUSHER. THE COIL WAS WITHDRAWN IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20242874 ↗MalfunctionJan 19, 2024Premature Separation; Premature Separation
PLEASE SEE SECTION H10 FOR INVESTIGATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18548514 ↗MalfunctionAug 6, 2023Premature Separation; Premature Separation
PLEASE SEE SECTION H10 FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17467282 ↗MalfunctionJul 13, 2023Premature Separation; Premature Separation
IT WAS ORIGINALLY REPORTED THAT THE COIL STRETCHED AND DID NOT DETACH; HOWEVER, ADDITIONAL INFORMATION RECEIVED STATED THAT AFTER THE OPERATOR FLUSHED THE COIL AND INSERTED IT INTO THE CATHETER, THE COIL WAS THEN ATTEMPTED TO BE ADVANCED THROUGH THE CATHETER. THE FIRST LOOP OF THE COIL MOVED OUT OF THE DISTAL TIP OF THE CATHETER, BUT THE OTHER REMAINING PART OF THE COIL WAS STUCK INSIDE THE CATHETER. THE OPERATOR TRIED TO RETRACT THE COIL, BUT THE COIL WAS ALREADY DETACHED. THE COIL AND CATHETER WERE BOTH REMOVED TOGETHER FROM THE PATIENT. THERE WAS NO INTERVENTION, AND NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17322348 ↗MalfunctionJul 13, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING A PELVIC CONGESTION PROCEDURE, THE EMBOLIZATION COIL IMPLANT UNINTENTIONALLY DETACHED. THE DETACHED COIL WAS PLACED IN INTENDED LOCATION AND ONE ADDITIONAL COIL WAS PLACED AND CASE COMPLETED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17320415 ↗MalfunctionJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionApr 27, 2023Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE COIL WAS SELECTED FOR THE EMBOLIZATION OF THE INTERNAL ILIAC ARTERY. REPORTEDLY PRIOR TO USE, THE COIL PACKAGING WAS NOTICED TO BE OPEN. THE COIL WAS NOT USED AND THE PHYSICIAN USED OTHER COILS TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16825736 ↗InjuryFeb 23, 2023Premature Separation; Premature Separation
MalfunctionNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PELVIC CONGESTION PROCEDURE, THE THIRD COIL DID NOT TRAVERSE THROUGH THE CATHETER AS SMOOTH AS THE PREVIOUS TWO. THE CATHETER DID HAVE A STEEP ANGULATION TO NEGOTIATE FROM RIGHT TO PATIENT LEFT. THE COIL WAS INSERTED AND REMOVED SEVERAL TIMES AS THE SURGEON ATTEMPTED TO LAND THE COIL IN DESIRED LOCATION. WHILE POSITIONING THE COIL, THE TECH WAS PLACING THE CONTROLLER ON THE BACK IN PREPARATION OF DEPLOYMENT. DURING REPOSITIONING AND/OR WHEN THE TECH WAS FOLLOWING WITH THE CONTROLLER, THE COIL SEPARATED WITHOUT INTENTIONAL DEPLOYMENT. THE COIL AND CATHETER WERE REMOVED AND RETRIEVED FROM WITHIN THE CATHETER. NO PATIENT INJURY RESULTED. PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF TWO ADDITIONAL COILS WITH SAME MICROCATHETER AFTER PREVIOUS COIL REMOVED. THE PROCEDURE COMPLETED SUCCESSFULLY AND NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12902371 ↗MalfunctionNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED FROM THE PUSHER IN THE VESSEL. THE PHYSICIAN WAS ABLE TO PULL THE COIL BACK INTO THE MICROCATHETER USING NEGATIVE PRESSURE WITH A SYRINGE AND THE COIL RETRIEVED AND REMOVED FROM PATIENT ALONG WITH THE CATHETER. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12901577 ↗MalfunctionAug 17, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED DURING TREATMENT OF A PAVM EMBOLIZATION, THE COIL WAS ADVANCED TO THE TREATMENT SITE WITH ENCOUNTERED RESISTANCE. THE COIL BECAME STUCK WITHIN THE MICROCATHETER AND WAS NOT MOVING. THE DELIVERY PUSHER WAS WITHDRAWN FROM THE CATHETER WITH THE IMPLANT REMAINING IN THE CATHETER. THE CATHETER WAS WITHDRAWN WITH THE COIL PARTIALLY EXTENDING AT THE CATHETER TIP. THE CASE WAS COMPLETED WITH ANOTHER COIL. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12332513 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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