Azur Detachable Helical HydroCoil 45-481015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170018008), received between Dec 23, 2016 and Feb 23, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2022Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A LEFT HEPATIC ARTERY ANEURYSM, THE COIL WAS RETRACTED AND POSITIONED WITHOUT ENCOUNTERED RESISTANCE. THE COIL WAS REPORT TO HAVE DETACHED FROM THE DELIVERY PUSHER. ATTEMPTS WERE MADE TO RETRACT AND ADVANCE THE COIL UNSUCCESSFULLY. THE MAJORITY OF THE COIL REMAINED WITHIN THE MICROCATHETER WHICH WAS STILL POSITIONED WITHIN THE COMMON HEPATIC ARTERY AND CELIAC TRUNK. THE COIL WAS SNARED WITHIN THE 5FR BASE CATHETER VIA THE MICRO CATHETER. THE PROXIMAL PORTION OF THE COIL WAS SUCCESSFULLY SNARED, HOWEVER ONLY A SMALL PORTION OF THE COIL WAS RETRIEVED ON RETRACTION. THE MAIN PORTION OF THE COIL WAS DEPLOYED WITHIN THE DISTAL COMMON HEPATIC ARTERY AND PROXIMAL COMMON HEPATIC ARTERY BY INJECTION OF SALINE VIA THE BASE CATHETER. AS THIS WAS NON-OCCLUSIVE, THE COIL WAS LEFT IN SITU. ON REMOVAL OF THE BASE CATHETER IT WAS REPORTED THAT THERE REMAINED A LONG ATTACHED, UNRAVELED PORTION OF COIL EXTENDING BACK TO THE CELIAC AXIS, AORTA AND RIGHT COMMON ILIAC ARTERY. PATIENT IS NOT SHOWING SYMPTOMS FROM THE MAL-POSITIONED COIL AT THIS TIME. NO PATIENT HARM OR INJURY WAS REPORTED. NO FURTHER TREATMENT IS PLANNED TO ADDRESS THE UNRAVELED PORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586635 ↗
• 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 7916754 ↗
• 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 7916752 ↗
• MalfunctionDec 23, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED A COIL WAS DEPLOYED BUT WOULD NOT TAKE CORRECT SHAPE OR DESIRED POSITION. AFTER MULTIPLE MANIPULATION ATTEMPTS, THE COIL SEPARATED FROM PUSHER WIRE INSIDE THE MICROCATHETER. BOTH COIL AND MICROCATHETER WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6203399 ↗