Azur CX Detachable 45-780828Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810170018336), received between Feb 7, 2018 and Jul 18, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Premature Separation; Premature Separation

  UPDATED INFORMATION WAS RECEIVED. NO INTERVENTION WAS NEEDED. THE COIL STRETCHED AND WAS REMOVED FROM THE BODY WITH NO ISSUE. IT DID NOT DETACH. OUTCOME OF PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549406 ↗
• MalfunctionJun 25, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE, THE COIL WAS ADVANCED INTO THE PATIENT AND THE PHYSICIAN DECIDED TO RECAPTURE THE COIL. WHEN TRYING TO REMOVE THE COIL IT DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM THE PATIENT WITH THE COIL INSIDE. THE MICROCATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330660 ↗
• MalfunctionApr 24, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING SPECIAL PROCEDURE, THE COIL DETACHED ON ITS OWN WITHOUT THE CONTROLLER. THE COIL DETACHED WHILE INSIDE THE PATIENT. THEY LEFT THE COIL IN THE PATIENT. THERE ARE NO PLANS TO REMOVE THE COIL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905827 ↗
• MalfunctionNov 7, 2024Premature Separation; Premature Separation

  NO ADDITIONAL INFORMATION OR CLARIFICATION WAS RECEIVED. PLEASE SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632411 ↗
• MalfunctionJun 4, 2024Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED: DURING SPLENIC PSEUDOANEURYSM COILING, THEY HAD AN 8X28 COIL BREAK INSIDE THE MICROCATHETER WHILE TRYING TO RECAPTURE THE COIL. COIL WAS REMOVED. THE CASE WAS COMPLETED & THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463974 ↗
• MalfunctionOct 20, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE, WHILE ADVANCING THE COIL IN THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED. THE COIL APPEARED TO HAVE FORMED IN THE CATHETER AND WOULD NOT ADVANCE FURTHER OUT OF THE PROXIMAL END OF THE CATHETER. THE COIL AND CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981467 ↗
• MalfunctionOct 5, 2018Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE COIL IN THE MICROCATHETER, THE COIL STRETCHED FROM THE PUSHER WIRE AND THEN DETACHED. BOTH SEGMENTS OF THE COIL 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 7940151 ↗
• MalfunctionMar 16, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, RESISTANCE WAS ENCOUNTERED IN THE MICROCATHETER. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED ALONG WITH THE MICROCATHETER IN THEIR ENTIRETY. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO HAVE NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7347353 ↗
• MalfunctionFeb 7, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE RE-POSITIONING AN EMBOLIZATION COIL IN A SPLENIC ANEURYSM, THE COIL DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THE COIL WAS PUSHED INTO THE INTENDED AREA WITH A PUSHER WIRE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7250288 ↗