Azur Detachable Helical HydroCoil 45-480610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810170017933), received between Nov 19, 2018 and Feb 11, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.

• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN IN INTERVENTIONAL RADIOLOGY, THE DEVICE'S RELEASE WIRE BROKE DURING USE, PREVENTING USE OF THE EQUIPMENT WITH THE RELEASE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360458 ↗
• MalfunctionMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8589298 ↗
• MalfunctionMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8589125 ↗
• InjuryMar 16, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A GASTROINTESTINAL BLEED, THE COIL DETACHED WITHOUT USE OF THE V-GRIP CONTROLLER. THE COIL WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426894 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COIL DETACHED WITHOUT THE USE OF THE DETACHMENT CONTROLLER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. 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 8087757 ↗