Azur CX Detachable 45-780724Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810170018329), received between Sep 27, 2018 and Mar 29, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING UNSPECIFIED EMBOLIZATION PROCEDURE, THE AZUR 18 XC COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE MICROCATHETER ALONG WITH THE COIL WERE REMOVED FROM THE PATIENT. ANOTHER COIL WAS USED 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 19008836 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE CATHETER MOVED FROM THE INTENDED LOCATION. THE SYSTEM WAS REMOVED. THE COIL WAS DETACHED FROM THE DELIVERY PUSHER WITHOUT THE USE OF THE DETACHMENT CONTROLLER. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853458 ↗
• MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290165 ↗
• MalfunctionFeb 8, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED FOR A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON A PATIENT ENROLLED IN A CLINICAL TRIAL. AFTER THE BALLOON HAD BEEN INFLATED IN THE INTERNAL CAROTID ARTERY (ICA), TWO COIL LOOPS OF THE FIRST COIL HERNIATED OUT OF THE ANEURYSM DOME INTO THE SUBARACHNOID SPACE. TWO ADDITIONAL COILS WERE SUBSEQUENTLY PLACED WITH THE BALLOON INFLATED. A CONTRAST INJECTION IN THE ICA AFTER DEFLATION OF THE BALLOON DEMONSTRATED NO EXTRAVASATION AND A FOLLOW-UP CT PERFORMED POST-PROCEDURE SHOWED NO EVIDENCE OF HEMORRHAGE. THE PATIENT WAS DISCHARGED HOME WITH MINIMAL RESIDUAL DEFICIT FROM THE INITIAL (PRE-TREATMENT) HEMORRHAGE FOLLOWING A 10-DAY STAY IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8320707 ↗
• InjuryJan 23, 2019Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component; Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO COIL THE GASTRODUODENDAL ARTERY (GDA). THE COIL WAS FORMING NICELY, BUT THE MICROCATHETER LOST ACCESS TO THE VESSEL. THE PHYSICIAN RETRACTED THE COIL AND WAS ABLE TO REGAIN ACCESS TO THE VESSEL. AN ATTEMPT WAS MADE TO DEPLOY THE COIL. THE COIL WAS DEPLOYED APPROXIMATELY 75% IN THE GDA WHERE IT WAS SUPPOSED TO BE; HOWEVER, THE COIL DETACHED FROM THE PUSHER WIRE AND SOME OF THE COIL WAS LEFT HANGING IN THE HEPATIC ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE COIL WITH A SNARE DEVICE, BUT WERE UNSUCCESSFUL. THE PHYSICIAN DECIDED TO DEPLOY A COVERED STENT IN THE HEPATIC ARTERY TO AFFIX THE REMAINING COIL AGAINST THE WALL OF THE ARTERY AND THE WALL OF THE STENT, WHICH ALLOWED THE PATIENT'S ARTERY TO REMAIN PATENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8272811 ↗
• InjurySep 27, 2018Migration; Migration

  IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916757 ↗