Azur Detachable Helical HydroCoil 45-480310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810170017889), received between Apr 7, 2017 and May 8, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Migration; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING TREATMENT OF A GASTRODUODENAL ARTERY (GDA) BLEED, THE THIRD EMBOLIZATION COIL IMPLANT TO BE IMPLANTED WAS NOT TAKING SHAPE IMMEDIATELY AND SO THE MICROCATHETER WAS USED TO COMPACT IT. WHEN ADVANCEMENT OF THE PUSHER WAS RESUMED, IT WAS NOTICED THAT THE IMPLANT HAD DETACHED UNEXPECTEDLY. THE CATHETER WAS FLUSHED WITH SALINE, WHICH MANUALLY PUSHED THE COIL OUT OF IT BUT ALSO CAUSED THE CATHETER TO LOSE POSITION AND BACK UP INTO THE HEPATIC ARTERY. THE IMPLANT COIL WAS THEN REPORTED TO HANGING INTO THE HEPATIC ARTERY, AT WHICH POINT THE BACK HALF OF THE COIL MIGRATED UP AND INTO THE LEFT HEPATIC ARTERY, WHERE IT STARTED TO TAKE ITS HELICAL SHAPE. IT WAS REPORTED TO HAVE A DUMBBELL SHAPE. ONE END OF THE IMPLANT WAS IN THE GDA, THEN IT STRAIGHTENED OUT AND UP INTO THE LEFT HEPATIC ARTERY WHERE THE OTHER END COILED AGAIN. THE GDA WAS OCCLUDED AND ACHIEVED THE RESULT DESIRED BY THE PHYSICIAN REGARDING THE EXISTING GDA BLEED. IT WAS REPORTED THAT, UPON FOLLOW UP, THE PATIENT HAD BEEN CONTINUING TO BLEED AND EXHIBITED SIGNS OF LIVER SHOCK. THE PATIENT LATER PASSED AWAY. IT WAS REPORTED THAT THE PHYSICIAN STATED THAT THE IMPLANT COIL DID NOT CONTRIBUTE TO THE PATIE

  Patient problems: Obstruction/Occlusion

  MAUDE report 19271597 ↗
• InjuryJun 13, 2018Detachment Of Device Component; Difficult to Remove; Separation Failure; Detachment Of Device Component; Difficult to Remove; Separation Failure

  IT WAS REPORTED THAT DURING PLACEMENT OF THE THIRD EMBOLIZATION COIL IN THE RIGHT GASTRIC ARTERY, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL DETACHED. THE DETACHED COIL WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599274 ↗
• InjuryApr 7, 2017Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL IN A SPLENIC PSEUDO ANEURYSM, RESISTANCE WAS ENCOUNTERED AND THE COIL UNEXPECTEDLY DETACHED FROM THE PUSHER WIRE. THE DETACHED DISTAL COIL SEGMENT WAS RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6470871 ↗