Azur Detachable Framing CoilRecalls & reported problems across all models
Microvention, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 7 models of Azur Detachable Framing Coil by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2016 and Jun 17, 2026 — classified as 14 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (24 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
Reports received per month, all models
Most reported Azur Detachable Framing Coil problems
Device problems
- Detachment of Device or Device Component24
- Device-Device Incompatibility10
- Detachment Of Device Component9
- Premature Separation8
- Device Issue4
- Difficult to Remove4
- Migration4
- Physical Resistance/Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient17
- Aneurysm4
- No Known Impact Or Consequence To Patient3
- Perforation of Vessels1
Azur Detachable Framing Coil models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Azur Detachable Framing Coil 45-652050Device, Vascular, for Promoting Embolization17 reports
- Azur Detachable Framing Coil 45-682050Device, Vascular, for Promoting Embolization8 reports
- Azur Detachable Framing Coil 45-651434Device, Vascular, for Promoting Embolization6 reports
- Azur Detachable Framing Coil 45-681434Device, Vascular, for Promoting Embolization6 reports
- Azur Detachable Framing Coil 45-680820Device, Vascular, for Promoting Embolization5 reports
- Azur Detachable Framing Coil 45-651026Device, Vascular, for Promoting Embolization3 reports
- Azur Detachable Framing Coil 45-650820Device, Vascular, for Promoting Embolization2 reports
Recent Azur Detachable Framing Coil adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540879 ↗MalfunctionFeb 11, 2026Physical Resistance/Sticking; Premature Separation
MalfunctionFeb 11, 2026Physical Resistance/Sticking; Premature Separation
MalfunctionJun 25, 2025Premature Separation; Premature Separation
AS REPORTED, PHYSICIAN GAINED ACCESS AND NAVIGATED DELIVERY CATHETER TO LOCATION. INSERTED THE COIL INTO THE MICROCATHETER. WHEN DELIVERING PHYSICIAN FELT RESISTANCE DUE TO THE EXTREME TORTUOSITY OF THE VESSEL. COIL DETACHED FROM PUSHER WIRE WITHIN CATHETER. THE COIL AND CATHETER WERE REMOVED AND THE PROCEDURE WAS CONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22325265 ↗InjuryMay 27, 2025Premature Separation; Premature Separation
AS REPORTED, THE FRAMING COIL RELEASED PREMATURELY AND GOT STUCK IN THE CATHETER. THE COIL WAS SNARED, AND THE CASE WAS ABLE TO BE COMPLETED USING OTHER COILS. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22093016 ↗InjuryMar 10, 2025Premature Separation; Premature Separation
AS REPORTED VIA MEDWATCH #MW5166353: 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. ADDITIONAL INFORMATION RECEIVED: BOTH COILS DETACHED INSIDE THE CATHETER. THE PHYSICIAN RETRIEVED BOTH COILS WITH SNARES. THE CASE COMPLETED WITH OTHER COILS. PATIENT DISCHARGED HOME SAME DAY WITH NO READMISSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567252 ↗MalfunctionJan 14, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation
AS REPORTED: DURING SPLENIC ARTERY ANEURYSM EMBOLIZATION, THE PHYSICIAN NOTICED CONSIDERABLE RESISTANCE AS HE ADVANCED THIS COIL THROUGH THE MICROCATHETER. THIS WAS NOT THE FIRST COIL OR LAST COIL TO BE ADVANCED THROUGH THIS SYSTEM. THE PHYSICIAN RECAPTURED THE COIL TO FLUSH THE SYSTEM AND TRY AGAIN. THE COIL WAS RETRACTED INTO THE COIL SHEATH, AFTER THE COIL WAS APPROXIMATELY HALFWAY INTO THE COIL SHEATH. THE COIL DETACHED FROM THE PUSHER WIRE, LEAVING THE COIL HALF INSIDE THE MICROCATHETER AND HALFWAY OUT OF IT. THE COIL WAS PULLED FROM THE CATHETER AND DISCARDED. ADDITIONAL COILS WERE ADVANCED AFTER THIS POINT WITH NO FURTHER RESISTANCE ISSUES. THE COIL MUST HAVE BROKE SOME TIME AFTER THE PROXIMAL END WAS IN THE PROTECTIVE SHEATH BECAUSE WHEN THE COIL WAS PULLED OUT AND AWAY FROM THE MICROCATHETER HUB, THE COIL REMAINED HALF INSIDE AND HALF OUTSIDE OF THE MICROCATHETER. THERE WAS APPROXIMATELY 10- 15 CM OF COIL OUTSIDE OF THE MICROCATHETER, ALLOWING FOR THE PHYSICIAN TO GRAB IT WITH HIS HAND AND REMOVE IT FROM THE MICROCATHETER NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21153252 ↗InjuryOct 14, 2024Migration; Separation Problem; Difficult or Delayed Separation; Migration; Separation Problem; Difficult or Delayed Separation
AS REPORTED, FAULTY RELEASE SYSTEM. REMOVAL OF THE COIL BY LASSO. NO CONSEQUENCES FOR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447494 ↗InjuryJul 9, 2024Separation Problem; Separation Problem
AS REPORTED: DURING A PROXIMAL SPLENIC EMBO, DR. HAD A 30CM SHEATH IN THE AORTA AND A 100CM 4FR ANGLED CATHETER IN THE SPLENIC ARTERY. THE ARTERY MEASURED 8-9MM IN DIAMETER. THE FIRST COIL USED WAS AN 35 14X34 FRAMING COIL. DR. ADVANCED THE COIL TO THE TIP OF THE CATHETER AND IT BECAME STUCK. WITHIN A FEW SECONDS OF MANIPULATING THE COIL, DR. STATED THAT HE FELT LIKE THE COIL BROKE FREE. HE REMOVED WHAT WAS LEFT OF THE PUSHER WIRE AND INJECTED SALINE INTO THE CATHETER TO SHOOT THE COIL OUT INTO THE VESSEL. THE COIL LANDED WHERE HE WANTED, HOWEVER, A LONG PORTION OF THE PUSHER WIRE WAS STILL ATTACHED TO THE COIL. THE WIRE SNAPPED IN HALF, IT WASN'T THE COIL DETACHING LIKE HE SUSPECTED. THE WIRE PROLAPSED INTO A COLLATERAL VESSEL AND TRACKED ALL THE WAY BACK TO THE ORIGIN OF THE SPLENIC ARTERY. IT WAS NOTICED THAT THE CATHETER KINKED AT THE PROXIMAL PORTION OF THE SPLENIC ARTERY. FROM THERE, HE DECIDED TO CONTINUE THE PROCEDURE AND PUT A 45CM SHEATH UP INTO THE SPLENIC ARTERY ALONG WITH A NEW 4FR 100CM ANGLED CATHETER AND CONTINUED TO DEPLOY SIX 035 AZUR CX COILS WITHOUT INCIDENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19707223 ↗MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PLEASE SEE H10 FOR DEVICE INVESTIGATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16550757 ↗InjuryFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A COILING OF A BYPASS ANEURYSM, AFTER PLACING THE COIL. THE COIL WAS IN THE WRONG LUMEN AND UNINTENTIONALLY DETACHED WITHOUT THE USE OF THE CONTROLLER. THE COIL WAS RETRIEVED WITH A SNARE DERIVE AND HAS BEEN REMOVED COMPLETELY. THE PROCEDURE CONTINUED WITH OTHER COILS THAT WERE PLACED SUCCESSFULLY. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT AND NO SIGNIFICANT DELAY OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350733 ↗MalfunctionSep 24, 2022Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481142 ↗MalfunctionAug 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SPLENIC ANEURYSM EMBOLIZATION CASE, THE COIL COULDN'T GO THROUGH THE GLIDECATH. WHEN THE PHYSICIAN PULLED THE COIL OUT OF THE CATHETER, THE COIL DETACHED INSIDE. A NEW CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFUL. NO HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246160 ↗MalfunctionJun 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SPLENIC ARTERY ANEURYSM EMBOLIZATION PROCEDURE, THE COIL HAD RESISTANCE WHEN IT WAS ADVANCED THROUGH THE GLIDE CATHETER. WHEN THE PHYSICIAN PULLED THE PUSHER WIRE BACK TO REMOVE IT, THE COIL DETACHED. THE GLIDE CATHETER AND COIL WERE REMOVED TOGETHER SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734538 ↗MalfunctionJun 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SPLENIC ARTERY ANEURYSM EMBOLIZATION PROCEDURE, THE COIL HAD RESISTANCE WHEN IT WAS ADVANCED TO THE TIP OF THE CATHETER. WHEN THE PHYSICIAN REPOSITIONED THE CATHETER AWAY FROM THE VESSEL WALL, THE COIL WOULD NOT ADVANCE. THEN, THE COIL WAS ATTEMPTED TO BE REMOVED, BUT IT DETACHED. AN ATTEMPT TO INJECT THE COIL BY FLUSHING WAS PERFORMED AND THE PUSHER WAS USED TO ADVANCE THE COIL UNSUCCESSFULLY. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14702283 ↗
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
- AZUR14 models · 104 reports
- HydroSoft 3D26 models · 101 reports
- MicroPlex Helical Soft9 models · 8 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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