Azur Detachable Helical HydroCoil 45-450620Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810170014932), received between Sep 28, 2018 and Mar 15, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2023Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED. PLEASE SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546987 ↗
• MalfunctionOct 13, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE EMBOLIZATION TREATMENT THE COIL WAS ADVANCED IN THE CATHETER AND IT WAS OBSERVED THAT THE IMPLANT COIL WAS NOT VISIBLE. THE COIL WAS NOT LOCATED AT THE DISTAL END OF THE DELIVERY SYSTEM OR WITHIN THE CATHETER. THE COIL WAS NOT FOUND AT THE PREP AREA PRIOR TO INSERTION. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628428 ↗
• MalfunctionMay 27, 2021Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION OF THE GASTRODUODENAL ARTERY WITH AN EMBOLIZATION COIL IMPLANT, THE COIL DID NOT DETACH. DURING ATTEMPTED REMOVAL, THE EMBOLIZATION COIL UNRAVELED AND FRACTURED, EXTENDING INTO THE INFRARENAL ABDOMINAL AORTA. INTRAOPERATIVE CONSULTATION WITH VASCULAR SURGERY WAS MADE, WHOM RECOMMENDED THAT GIVEN THE PATIENT'S UNDERLYING MEDICAL COMORBIDITIES AND CONDITION, FURTHER ATTEMPTS AT RETRIEVAL OR REPOSITIONING OF THE EMBOLIZATION COIL SHOULD BE ABORTED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898274 ↗
• MalfunctionApr 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL CAME OFF UNEXPECTEDLY. NO INTERVENTION OR SEQUELA WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646888 ↗
• MalfunctionApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR PELVIC CONGESTION, WHEN TRYING TO RETRACT AN EMBOLIZATION IMPLANT COIL THROUGH THE CATHETER TO REPOSITION, THE IMPLANT DETACHED. THE CATHETER AND COIL WERE SUCCESSFULLY REMOVED FROM THE PATIENT TOGETHER. NO PATIENT INJURY OR INTERVENTION WAS REPORTED. THE PATIENT IS REPORTED TO BE "STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610839 ↗
• InjuryJan 9, 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 DURING RETRACTION. THE COIL WAS SUCCESSFULLY RETRIEVED WITH A SNARE FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143978 ↗
• InjurySep 28, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE, FRICTION WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THE COIL DEPLOYED WELL UNTIL THE LAST CENTIMETER, WHICH COULD NOT BE COMPLETELY PLACED AT THE TREATMENT SITE WITHOUT OVERFLOW OF THE COIL INTO THE CELIAC TRUNK. DURING THE ATTEMPT TO REMOVE THE COIL, RESISTANCE WAS ENCOUNTERED AND THE COIL DETACHED IN THE MICROCATHETER, LEAVING APPROXIMATELY 10CM OF THE COIL IN THE INTENDED TREATMENT AREA. THE COIL WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH A SNARE DEVICE. THERE WAS NO REPORTED CLINICAL SEQUELAE AS A RESULT OF THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920991 ↗