Azur Detachable Helical HydroCoil 45-451015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170014963), received between Jun 29, 2016 and Jul 26, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL IN THE PROXIMAL PORTION OF THE LEFT VARICOCELE VESSEL, THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL. THE COIL WAS HALF WAY OUT OF THE CATHETER, AND THE PHYSICIAN PULLED BACK ON THE COIL, AND THE COIL DETACHED IN THE CATHETER. AN ATTEMPT WAS MADE TO PUSH THE COIL INTO THE INTENDED AREA; HOWEVER, THE COIL HUNG DOWN INTO THE RENAL VEIN. THE COIL WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724534 ↗
• MalfunctionJun 29, 2016Device Issue; Positioning Problem; Device Issue; Positioning Problem

  IT WAS REPORTED FROM (B)(6) DURING EMBOLIZATION TREATMENT OF A VESSEL, THE COIL PREMATURELY DETACHED WITHOUT THE USE OF THE DETACHMENT CONTROLLER. NO INTERVENTION WAS REPORTED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5758893 ↗