Azur CX Detachable 45-781032Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810170018350), received between Oct 18, 2017 and Dec 13, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A PSEUDOANEURYSM THE THIRD COIL USED IN THE CASE BECAME STUCK, UNRAVELED WITH A PORTION OF THE COIL REMAINS IN THE PATIENT. THE FIRST AZUR CX COIL WAS FOLLOWED BY A COMPETITOR PUSHABLE COIL WHICH EXPERIENCED RESISTANCE IN A COMPETITOR CATHETER. THE PHYSICIAN PUSHED OUT THE COMPETITOR PUSHABLE COIL OUT OF THE CATHETER AND THEN ATTEMPTED TO PLACE AN AZUR COIL BEHIND IT; HOWEVER, IT GOT TANGLED UP IN THE COIL MASS. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE AZUR COIL, IT BECAME STUCK AND BEGAN TO UNRAVEL. THE PHYSICIAN SNARED SOME OF THE COIL OUT. A PORTION OF THE UNRAVELED COIL REMAINS IN THE PATIENT¿S BODY, FROM THE SMA TO THE AORTA AND DOWN NEAR THE FEMORAL ACCESS POINT. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE PATIENT IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974256 ↗
• MalfunctionSep 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PRE EVAR INTERNAL ILIAC ARTERY ANEURYSM EMBOLIZATION CASE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE EMBOLIZATION COIL THROUGH THE MICROCATHETER. THE COIL AND MICROCATHETER WERE RETRACTED AND UPON REMOVAL, THE COIL WAS OBSERVED TO BE DAMAGED/KINKED AND DETACHED FROM THE DELIVERY PUSHER. THE EMBOLIZATION CASE WAS CONTINUED SUCCESSFULLY WITH NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543982 ↗
• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE DURING INSERTION AND ADVANCING INTO THE MICROCATHETER AND UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT AND OTHER COILS OF THE SAME TYPE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. PATIENT REPORTED TO BE "STABLE." THIS IS REPORT 3 OF 4. REFERENCE MFR. REPORTS#: 2032493-2021-00246, 2032493-2021-00247, AND 2032493-2021-00249.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037983 ↗
• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE DURING INSERTION AND ADVANCING INTO THE MICROCATHETER AND UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT AND OTHER COILS OF THE SAME TYPE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. PATIENT REPORTED TO BE "STABLE." THIS IS REPORT 2 OF 4. REFERENCE MFR. REPORTS#: 2032493-2021-00246, 2032493-2021-00248, AND 2032493-2021-00249.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037970 ↗
• MalfunctionApr 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL DETACHED FROM THE DELIVERY PUSHER PRIOR TO DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683134 ↗
• MalfunctionOct 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE COIL, THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT IS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940159 ↗
• InjuryJul 13, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, A PREVIOUSLY IMPLANTED STENT STRUT OVERLAPPED THE NECK OF THE ANEURYSM, WHICH PREVENTED THE DELIVERY OF A 2F CATHETER. A 1.5 MM BALLOON AND A 2 MM BALLOON WERE USED TO DILATE THE STRUTS. CONTINUED RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE CATHETER. A NEW CATHETER WAS USED, WHICH WAS ABLE TO ADVANCE. RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPT TO PLACE THE COIL, AND THE COIL DETACHED FROM THE PUSHER WIRE. A 3 CC SYRINGE WITH SALINE WAS USED TO FLUSH THE DETACHED COIL INTO THE INTENDED TREATMENT AREA. DURING AN ATTEMPT TO PULL THE CATHETER BACK SLIGHTLY, THE CATHETER POSITION WAS LOST IN THE ANEURYSM INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND PART OF THE COIL WAS NOTED TO REMAIN THERE. THE CATHETER WAS PULLED INTO THE GUIDE AND A STENT WAS USED TO PIN THE COIL AGAINST THE PROXIMAL LAD AND INTO THE LEFT MEDIAL. THE COIL WAS LEFT IMPLANTED IN THE ASCENDING AORTA. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7686307 ↗
• MalfunctionOct 18, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE PATIENT'S ANATOMY WAS REPORTED TO BE TORTUOUS, AND THE COIL WAS MANIPULATED AGGRESSIVELY. THE COIL WAS REMOVED IN ITS ENTIRETY WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6960479 ↗