Azur Detachable Helical HydroCoil 45-480815Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810170017971), received between Aug 31, 2018 and Nov 4, 2021 — classified as 1 injury, 4 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.

• MalfunctionNov 4, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL DETACHED WITHIN THE MICROCATHETER. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY AND AS INTENDED. NO HARM OR SEQUELAE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755291 ↗
• MalfunctionJul 21, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A SPLENIC ARTERY EMBOLIZATION, THE PHYSICIAN ENCOUNTERED RESISTANCE DURING ADVANCEMENT. UPON RETRACTION, THE COIL HAD DETACHED. THE COIL WAS REMOVED WITHOUT INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207978 ↗
• MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A SPLENIC ARTERY ANEURYSM EMBOLIZATION, ACCESS ACHIEVED INTO SPLENIC ANEURYSM AND SUCCESSFULLY DELIVERED MULTIPLE EMBOLIZATION COILS. AN AZUR 45-480815 WAS INTRODUCED. THE COIL ADVANCED WITHOUT ISSUE TO DISTAL PORTION OF MICROCATHETER. ABOUT 1CM OF COIL WAS ADVANCED OUT OF MICROCATHETER BEFORE MICROCATHETER KICKED BACK. COIL RETRACTED AND RE-ADVANCED MULTIPLE TIMES TO ALLOW COIL TO SOFTEN. THE COIL BECAME STUCK AND WOULD NOT ADVANCE FURTHER. DURING ATTEMPT TO WITHDRAW THE COIL, IT DETACHED IN MICROCATHETER. MICROCATHETER AND COIL WERE REMOVED TOGETHER SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ADDITIONAL COILS. NO PATIENT HARM OR INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926002 ↗
• InjurySep 27, 2018Migration; Migration

  IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916753 ↗
• MalfunctionAug 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL, THE COIL DETACHED FROM THE PUSHER WHILE BEING RETRACTED. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE CATHETER. 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 7840098 ↗