Azur CX Detachable 45-780620Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810170018312), received between Jul 23, 2018 and Mar 4, 2026 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Premature Separation

  AS REPORTED: A COIL PREMATURELY DEPLOYED. THE COIL DETACHED OUTSIDE THE MICROCATHETER, INSIDE THE PATIENT. THEY DID NOT REMOVE THE COIL FROM THE PATIENT. THE CASE WAS COMPLETED BY PUTTING ADDITIONAL COILS IN FRONT OF THE OF CX COIL. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509814 ↗
• MalfunctionNov 30, 2023Component Missing; Component Missing

  IT WAS REPORT THAT, UPON OPENING THE PACKAGE, THE IMPLANT COIL WAS FOUND TO BE MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243702 ↗
• 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 1 OF 4. REFERENCE MFR. REPORTS#: 2032493-2021-00247, 2032493-2021-00248, AND 2032493-2021-00249.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037678 ↗
• MalfunctionSep 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ADVANCEMENT OF AN EMBOLIZATION COIL, THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10525817 ↗
• MalfunctionMar 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER PLACEMENT OF AN EMBOLIZATION COIL AT THE INTENDED TREATMENT SITE, THE COIL UNEXPECTEDLY DETACHED WITHOUT USE OF THE DETACHMENT CONTROLLER. THE COIL WAS PROPERLY PLACED AND THERE WAS NO ADDITIONAL INTERVENTION OR REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9802941 ↗
• MalfunctionFeb 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL DETACHED WITHIN THE MICROCATHETER WITHOUT USE OF THE CONTROLLER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9730236 ↗
• InjuryOct 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION OF THE GASTRODUODENAL ARTERY, IT WAS DECIDED THAT AN EMBOLIZATION COIL WOULD BE REMOVED FROM THE PATIENT INSTEAD OF IMPLANTING IT. HOWEVER, UPON REMOVAL, THE IMPLANT DETACHED FROM THE DELIVERY PUSHER. A SNARE WAS IMPLEMENTED TO REMOVE TO COIL FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258262 ↗
• MalfunctionFeb 28, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A RIGHT ILIAC VESSEL, THE COIL DID NOT DETACH AFTER SEVERAL ATTEMPTS. DURING REMOVAL, THE COIL DETACHED IN THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379140 ↗
• MalfunctionFeb 28, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A RIGHT ILIAC VESSEL, THE COIL DID NOT DETACH AFTER SEVERAL ATTEMPTS. DURING REMOVAL, THE COIL DETACHED IN THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379131 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ATTEMPT TO ADVANCE THE COIL, THE COIL DETACHED IN THE CATHETER. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY FROM THE PATIENT ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712664 ↗