Azur Detachable Helical HydroCoil 45-450815Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170014949), received between May 16, 2016 and Jun 2, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionJun 2, 2023Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED IN CONJUNCTION WITH AN EVAR PROCEDURE. INTERNAL ILIAC BRANCH MEASURED AROUND 9CM DISTALLY WITH INCREASING DIAMETER PROXIMALLY. REPORTEDLY, THE COIL EXPERIENCED EXTREME RESISTANCE IN THE 4FR 65CM ANGLED MICROCATHETER FROM ANOTHER MANUFACTURER AND COULD NOT BE ADVANCED. THE MICROCATHETER WAS EXCHANGED FOR A 5FR 100CM ANGLED CATHETER WITH NO REAL IMPROVEMENT. THE COIL UNRAVELED AND UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED WITH THE CATHETER. USE OF COILS WAS ABORTED WITH ONLY ONE COIL PLACED AND THE PHYSICIAN DECIDED TO CONTINUE WITHOUT FULL EMBOLIZATION. ONLY 1 OF 5 COILS WERE DEPLOYED SUCCESSFULLY. ANATOMY WAS NORMAL WITH NO TORTUOSITY. NO REPORT OF HARM OR INJURY TO THE PATIENT AND DESCRIBED AS "NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054516 ↗
• InjuryDec 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF THE EMBOLIZATION COIL, THE COIL DETACHED WITHOUT USE OF THE CONTROLLER. A SNARE DEVICE WAS SUCCESSFULLY USED TO REMOVE THE DETACHED COIL, WHICH WAS LOCATED BETWEEN THE HYPOGASTRIC AND THE FEMORAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162980 ↗
• MalfunctionJan 1, 2017Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position

  IT WAS REPORTED THAT DURING PLACEMENT OF THE AZUR EMBOLIZATION COIL, SOME RESISTANCE WAS ENCOUNTERED. DURING THE REPOSITIONING ATTEMPT, THE COIL BROKE FROM THE PUSHER WIRE. THE MICROCATHETER, DELIVERY SYSTEM, AND THE ENTIRE COIL WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6217018 ↗
• MalfunctionMay 16, 2016Detachment Of Device Component; Device Issue; Detachment of Device or Device Component; Detachment Of Device Component; Device Issue; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF AN ANEURYSM, THE COIL PREMATURELY DETACHED WITHIN THE CATHETER. THE COIL WAS PUSHED TO THE TARGET SITE AND THE DELIVERY PUSHER AND CATHETER WERE REMOVED SUCCESSFULLY AS A SYSTEM. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5658121 ↗