Azur Detachable Framing Coil 45-680820Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810170017742), received between Mar 22, 2019 and Jan 14, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  AS REPORTED: DURING SPLENIC ARTERY ANEURYSM EMBOLIZATION, THE PHYSICIAN NOTICED CONSIDERABLE RESISTANCE AS HE ADVANCED THIS COIL THROUGH THE MICROCATHETER. THIS WAS NOT THE FIRST COIL OR LAST COIL TO BE ADVANCED THROUGH THIS SYSTEM. THE PHYSICIAN RECAPTURED THE COIL TO FLUSH THE SYSTEM AND TRY AGAIN. THE COIL WAS RETRACTED INTO THE COIL SHEATH, AFTER THE COIL WAS APPROXIMATELY HALFWAY INTO THE COIL SHEATH. THE COIL DETACHED FROM THE PUSHER WIRE, LEAVING THE COIL HALF INSIDE THE MICROCATHETER AND HALFWAY OUT OF IT. THE COIL WAS PULLED FROM THE CATHETER AND DISCARDED. ADDITIONAL COILS WERE ADVANCED AFTER THIS POINT WITH NO FURTHER RESISTANCE ISSUES. THE COIL MUST HAVE BROKE SOME TIME AFTER THE PROXIMAL END WAS IN THE PROTECTIVE SHEATH BECAUSE WHEN THE COIL WAS PULLED OUT AND AWAY FROM THE MICROCATHETER HUB, THE COIL REMAINED HALF INSIDE AND HALF OUTSIDE OF THE MICROCATHETER. THERE WAS APPROXIMATELY 10- 15 CM OF COIL OUTSIDE OF THE MICROCATHETER, ALLOWING FOR THE PHYSICIAN TO GRAB IT WITH HIS HAND AND REMOVE IT FROM THE MICROCATHETER NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153252 ↗
• InjuryApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE FOR A PSEUDO-ANEURYSM, THE DELIVERY PUSHER OF AN EMBOLIZATION COIL IMPLANT SEPARATED INTO TWO PIECES. THE PHYSICIAN FLUSHED THE COIL INTO POSITION AND ATTEMPTED TO SNARE THE PART OF THE PUSHER STILL INSIDE OF THE PATIENT. PART OF THE COIL WAS REMOVED SUCCESSFULLY, HOWEVER A PORTION REMAINS WITHIN THE PATIENT. ADDITIONAL FLUORO TIME WAS NEEDED TO TRY TO RETRIEVE THE COIL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691608 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PORTAL VEIN EMBOLIZATION, AN EMBOLIZATION COIL IMPLANT DETACHED IN THE MICROCATHETER DURING RETRACTION. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600697 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL IN THE CATHETER. DURING REMOVAL, THE COIL DETACHED INSIDE THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE CATHETER. 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 8445502 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL IN THE CATHETER. DURING REMOVAL, THE COIL DETACHED INSIDE THE CATHETER. 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 8445444 ↗