Azur Detachable Helical HydroCoil 45-482030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810170018084), received between Feb 21, 2018 and Aug 16, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionAug 16, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT A EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY WHILE THE DISTAL THIRD OF COIL WAS IN THE ANEURSYM SAC. THE MICROCATHETER WAS REMOVED WITH THE COIL INSIDE. THE CASE WAS COMPLETED WITH OTHER COILS. THERE WAS NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17554268 ↗
• MalfunctionAug 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A SPLENIC ARTERY ANEURYSM, AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY WITHIN THE MICROCATHETER. A SALINE FLUSH WAS USED TO PUSH THE COIL INTO THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353312 ↗
• MalfunctionJan 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL DETACHED IN THE MICROCATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182454 ↗
• MalfunctionAug 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EMBOLIZATION COIL UNEXPECTEDLY DETACHED INSIDE THE MICROCATHETER WITHOUT USE OF THE DETACHMENT CONTROLLER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10469094 ↗
• MalfunctionFeb 21, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE EMBOLIZATION COIL WAS ADVANCED OUT FROM THE TIP OF THE INTRODUCER SHEATH AND THE COIL WAS FOUND TO BE DETACHED. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7286695 ↗