Azur Detachable Helical HydroCoil 45-481220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170018039), received between Jan 6, 2017 and Apr 17, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION, THE EMBOLIZATION COIL DETACHED WHEN IT WAS SOAKED IN WARM SALINE SOLUTION. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8525480 ↗
• MalfunctionAug 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE ADVANCING AN EMBOLIZATION COIL, THE COIL DETACHED IN THE MICROCATHETER. THE HYDROGEL COIL SWELLED IN THE MICROCATHETER AND WAS STUCK, SO THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801833 ↗
• InjuryJan 15, 2017Detachment Of Device Component; Migration or Expulsion of Device; Detachment Of Device Component; Migration or Expulsion of Device

  IT WAS REPORTED THAT COIL EMBOLIZATION OF THE GONADAL VEIN FOR A VARICOCELE WAS ATTEMPTED. DURING THE PROCEDURE, THE CATHETER "CAME BACK" AND THE AZUR CX COIL UNEXPECTEDLY DETACHED, BUCKLED, AND WENT INTO THE RENAL VEIN. THE DETACHED COIL WAS REMOVED WITH A WIRE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6252927 ↗
• InjuryJan 6, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE AZUR EMBOLIZATION COIL DETACHED UNEXPECTEDLY WITHOUT USE OF THE CONTROLLER. THE COIL WAS SUCCESSFULLY SNARED AND WITHDRAWN WITHOUT FURTHER INCIDENT. THE PATIENT IS REPORTED TO BE STABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6231391 ↗