Azur Detachable Helical HydroCoil 45-480615Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170017940), received between Dec 26, 2018 and Nov 11, 2022 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION, THE COIL DID NOT DETACH INITIALLY WITH THE USE OF THE DETACHER; HOWEVER, THE COIL UNINTENTIONALLY DETACHED WITHOUT FURTHER ATTEMPT WITH THE CONTROLLER. THE DEVICE IS IMPLANTED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784920 ↗
• InjuryAug 26, 2020Migration or Expulsion of Device; Separation Failure; Detachment of Device or Device Component; Migration or Expulsion of Device; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER PLACEMENT OF AN EMBOLIZATION COIL IN A FISTULA, THE COIL WOULD NOT DETACH AFTER THREE ATTEMPTS AND THE USE OF TWO DIFFERENT CONTROLLERS. AS THE COIL WAS BEING REMOVED, IT BECAME LODGED IN THE CATHETER AND DURING THE ATTEMPT TO REMOVE THE COIL AND CATHETER TOGETHER, THE COIL DETACHED AND MIGRATED TO THE RIGHT VENTRICLE AND THEN TO THE PULMONARY ARTERY. THE DETACHED COIL WAS SNARED FROM THE PATIENT IN A SUBSEQUENT PROCEDURE. THERE WAS NO REPORTED SEQUELAE. THE PATIENT IS REPORTED TO HAVE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457761 ↗
• MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE POSITIONING THE DEVICE IN THE VESSEL, THE IMPLANT SEPARATED FROM THE DELIVERY PUSHER. THE COIL AND DELIVERY PUSHER WERE REMOVED TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756220 ↗
• MalfunctionDec 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED WITHOUT USE OF THE CONTROLLER. BOTH SEGMENTS OF THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196914 ↗