Azur Detachable Helical HydroCoil 45-451020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170014970), received between Jun 12, 2018 and Apr 11, 2022 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A RENAL ANEURYSM, THE COIL ADVANCED INTO THE CATHETER WITHOUT INCIDENT. RESISTANCE WAS ENCOUNTERED AS THE COIL WAS ADVANCED INTO THE COIL MASS. THE COIL WAS WITHDRAWN AND ATTEMPTED TO REPOSITION THE CATHETER. THE COIL WAS RE-ADVANCED HOWEVER, RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT DURING MANIPULATION, THE COIL DETACHED FROM THE DELIVERY PUSHER. ADDITIONAL COILS WERE DELIVERED WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPETED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079851 ↗
• MalfunctionAug 18, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER THE IMPLANT COIL PARTLY EMERGED FROM THE CATHETER, THE COIL STOPPED ADVANCING. DURING THE ATTEMPT TO REMOVE THE DEVICE, THE COIL DETACHED FROM THE PUSHER WIRE. A .035 GUIDE WIRE WAS USED TO PUSH THE IMPLANT COIL INTO THE TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "STABLE/UNREMARKABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423558 ↗
• MalfunctionMar 14, 2020Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS PERFORMED IN AN INTERNAL ILIAC ARTERY. DURING DELIVERY OF THE 8TH COIL, THE FIRST 2-3 LOOPS FORMED WITHOUT ISSUE, BUT ADVANCING THE COIL BECAME MORE DIFFICULT. THE CATHETER WAS MANIPULATED AND THE COIL WAS RE-ADVANCED SEVERAL TIMES OVER THE SPAN OF APPROXIMATELY 4.5 MINUTES UNTIL THE COIL WOULD NO LONGER ADVANCE. DURING THE WITHDRAWAL ATTEMPT, THE COIL DETACHED IN THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED TOGETHER WITH THE CATHETER WITHOUT INCIDENT. THE SAME CATHETER WAS REINSERTED AND USED TO SUCCESSFULLY DEPLOY 3 MORE COILS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832967 ↗
• MalfunctionJun 12, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL IN A PSEUDO ANEURYSM, THE COIL DETACHED IN THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594608 ↗