Azur Detachable Framing Coil 45-652050Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00810170016158), received between Aug 9, 2016 and Jun 25, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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, 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT UNEXPECTEDLY DETACHED IN THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722087 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION PROCEDURE, THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10577704 ↗
• MalfunctionAug 9, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE IMPLANT COIL BECAME STUCK AFTER ENCOUNTERING RESISTANCE DURING ADVANCEMENT. DURING RETRACTION OF THE DELIVERY PUSHER, IT WAS NOTICED THAT THE IMPLANT COIL MAY HAVE BECOME DETACHED. THE DELIVERY PUSHER WAS REMOVED, AND THE COIL WAS NOT PRESENT AT THE TIP. AN ATTEMPT WAS MADE TO ADVANCE THE IMPLANT COIL INTO THE ANEURYSM WITH THE GUIDEWIRE, BUT THE COIL WAS STUCK IN THE MICROCATHETER. THE DETACHED COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. APPROXIMATELY HALF OF THE DETACHED COIL WAS PROTRUDING FROM THE TIP OF THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880683 ↗
• MalfunctionNov 21, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COIL GOT STUCK IN THE MICROCATHETER AND DURING THE REMOVAL ATTEMPT, THE COIL DETACHED. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097915 ↗
• MalfunctionOct 2, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ADVANCEMENT THROUGH A 4F CATHETER, THE EMBOLIZATION COIL BECAME STUCK. DURING THE ATTEMPT TO REMOVE THE COIL, IT DETACHED IN THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED FROM THE PATIENT TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926392 ↗
• MalfunctionJun 4, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AN EMBOLIZATION COIL GOT STUCK IN THE CATHETER AND DETACHED. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567912 ↗
• MalfunctionNov 30, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT COIL EMBOLIZATION TREATMENT WAS ATTEMPTED ON AN AORTOCAVAL FISTULA. AN AMPLATZER PLUG HAD JUST BEEN PLACED AT THE TREATMENT SITE, AND A C2 CATHETER WAS ADVANCED BEYOND THE PLUG. AS THE AZUR COIL WAS BEING ADVANCED THROUGH THE C2 CATHETER, RESISTANCE WAS ENCOUNTERED AFTER 50% OF THE COIL WAS OUT OF THE CATHETER. THE COIL WAS PUSHED HARDER UNTIL THE COIL BECAME STUCK AND COULD NOT BE ADVANCED OR WITHDRAWN. DURING REMOVAL WITH FORCE, THE COIL DETACHED INSIDE THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072594 ↗
• MalfunctionOct 3, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING REPOSITIONING OF AN EMBOLIZATION COIL, THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT'S STATUS IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909852 ↗
• InjuryApr 27, 2017Detachment Of Device Component; Difficult to Remove; Device-Device Incompatibility; Detachment Of Device Component; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EMBOLIZATION COIL PROCEDURE, RESISTANCE WAS ENCOUNTERED IN THE MICROCATHETER. DURING AN ATTEMPT TO REMOVE THE COIL, THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE DETACHED COIL WAS RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525714 ↗
• MalfunctionSep 7, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED THAT DURING A TRANSCAVAL COILING TREATMENT, DIFFICULTY DURING ADVANCEMENT OF THE CATHETER WAS ENCOUNTERED. THE SITE WAS ACCESSED AND COILS WERE PLACED INTO CATHETER SUCCESSFULLY. THE COIL IN COMPLAINT WOULD NOT ADVANCE OUT OF THE CATHETER TIP. UPON WITHDRAWAL, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE COIL COULD NOT BE PUSHED OR FLUSHED. THE DEVICE WAS PULLED FROM THE CATHETER AND REPORTED TO STRETCH. THE DEVICE WAS REMOVED AND THE SAME CATHETER WAS USED TO DEPLOY ADDITIONAL COILS. NO ADDITIONAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS INCURRED DUE TO THIS INCIDENT.

  Patient problems: Aneurysm

  MAUDE report 5934713 ↗
• InjuryAug 9, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL WOULD NOT FULLY ADVANCE FROM THE MICROCATHETER. UPON WITHDRAWAL OF THE COIL, IT PREMATURELY DETACHED FROM THE DELIVERY PUSHER WITHIN THE MICROCATHETER. A BENTSON WIRE WAS USED TO TRY TO PUSH THE COIL OUT (ADVANCE) FROM THE MICROCATHETER UNSUCCESSFULLY. THE CATHETER WAS REMOVED AND IN DOING SO THE COIL PARTIALLY DEPLOYED WITH IN THE VESSEL BIFURCATION. THE OTHER PORTION OF THE COIL WAS PULLED WITH THE SHEATH. THE COIL WAS PULLED AND STRETCHED UNTIL IT WAS COMPLETELY REMOVED. THE ENTIRE COIL WAS REMOVED IN ONE PIECE BY STRETCHING. NO HARM OR INJURY WAS REPORTED DUE TO THIS INCIDENT.

  Patient problems: Aneurysm

  MAUDE report 5857811 ↗