Azur Detachable Helical HydroCoil 45-451220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170014994), received between Oct 21, 2016 and Nov 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE DOCTOR DEPLOYED THE COIL DURING A PAVM EMBOLIZATION PROCEDURE, IT DID NOT WORK. THE COIL WAS ADVANCED THROUGH A MICROCATHETER, AND IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. NO DETACHMENT CONTROLLER WAS USED. A FLUOROSCOPY SHOWED THAT THE COIL WAS DETACHED INSIDE THE MICROCATHETER. BOTH THE COIL AND MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT. NO PATIENT INJURY OR INTERVENTION WAS REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243786 ↗
• MalfunctionOct 21, 2016Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT THE AZUR EMBOLIZATION COIL WOULD NOT DETACH. DURING THE ATTEMPT TO REPOSITION THE COIL, IT DETACHED IN THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6049509 ↗