Azur Detachable Helical HydroCoil 45-480620Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810170017957), received between Sep 6, 2017 and Sep 13, 2023 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER AND COIL WERE WITHDRAWN TOGETHER SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17734631 ↗
• MalfunctionMay 18, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PULLING THE COIL BACK INTO THE CATHETER TO REPOSITION AND IT DETACHED ON ITS OWN. ONLY 3CM OF THE COIL WAS ADVANCED OUT OF THE DISTAL END OF THE CATHETER WHEN THE PHYSICIAN DECIDED TO REPOSITION. THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED COIL BY REMOVING THE CATHETER. THE CATHETER WAS REINTRODUCED, AND THE CASE WAS SUCCESSFULLY COMPLETED WITH NO HEALTH EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957829 ↗
• MalfunctionApr 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION CASE, THE AZUR COIL DID NOT DETACH AFTER IT WAS DEPLOYED AND POSITIONED. THEN THE PHYSICIAN UTILIZED THE DETACHMENT CONTROLLER AGAIN BUT THE COIL STILL DID NOT DETACH. REPORTEDLY, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHEN IT WAS ATTEMPTED TO WITHDRAW THE COIL. THE PHYSICIAN WITHDREW THE CATHETER AND FLUSHED THE CATHETER TO REMOVE THE COIL THEN CONTINUED THE CASE BY UTILIZING OTHER COILS. NO REPORT OF HARM OR INJURY TO THE PATIENT, WHO WAS REPORTEDLY STABLE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219225 ↗
• InjurySep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER WHEN THEY PHYSICIAN WAS ATTEMPTING TO ADVANCE AND DEPLOY THE COIL INTO THE GASTRODUODENAL ARTERY (GDA). THE COIL FLOATED OUT OF THE MICROCATHETER AND BECAME DISLODGED IN THE HEPATIC ARTERY (NON-TARGETED EMBOLIZATION). THE PHYSICIAN ATTEMPTED TO SNARE THE COIL BUT WAS UNSUCCESSFUL AND THE COIL WAS LEFT IN PATIENT. THE PATIENT REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418775 ↗
• InjuryMar 26, 2021Difficult to Remove; Detachment of Device or Device Component; Migration; Difficult to Remove; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING TREATMENT OF THE GASTRODUODENAL ARTERY (GDA), THE EMBOLIZATION COIL IMPLANT DETACHED BEFORE BEING POSITIONED. THE COIL MIGRATED FROM THE GDA TO THE RIGHT HEPATIC ARTERY. THE COIL WAS RETRIEVED WITH A SNARE DEVICE AFTER 3 HOURS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573171 ↗
• InjuryDec 20, 2018Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Difficult to Remove; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER PLACEMENT OF MULTIPLE EMBOLIZATION COILS IN A SPLENIC ANEURYSM, THE LAST COIL CAME BACK WITH THE CATHETER SYSTEM DURING WITHDRAWAL. CONTRALATERAL ACCESS WAS OBTAINED AND THE COIL WAS RETRIEVED WITH A SNARE. A POST-PROCEDURE CT PERFORMED LATER THAT EVENING DEMONSTRATED A SEGMENT OF THE COIL POSITIONED OVER THE AORTIC BIFURCATION WITH AN END IN EACH OF THE COMMON ILIAC ARTERIES. THE FOLLOWING DAY, THE PATIENT RETURNED FOR AN ADDITIONAL PROCEDURE, IN WHICH THE COIL SEGMENT WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE ISSUE. THE PATIENT IS REPORTED TO HAVE MADE A FULL RECOVERY AND IS FINE NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187162 ↗
• MalfunctionOct 12, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT TWO (2) SEPARATE V-GRIP CONTROLLERS WERE USED TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL UNEXPECTEDLY DETACHED IN THE TIP OF THE MICROCATHETER. THE COIL WAS PUSHED INTO THE INTENDED AREA WITH A GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT PATIENT'S STATUS IS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6947004 ↗
• MalfunctionSep 6, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COIL GOT STUCK IN THE MICROCATHETER DURING ADVANCEMENT OF AN EMBOLIZATION COIL TO THE INTENDED AREA. THE COIL WAS THEN "PUSHED HARD" TO ADVANCE THE COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED. DURING RETRACTION OF THE COIL, THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6847345 ↗