Azur Detachable Helical HydroCoil 45-480820Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170017988), received between Jun 21, 2018 and Apr 6, 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 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A SPLENIC ARTERY, THE COIL DID NOT RESPOND DURING POSITIONING. IT WAS THOUGHT THAT THE COIL DETACHED FROM THE DELIVERY PUSHER. THE COIL SYSTEM AND MICROCATHETER WERE WITHDRAWN TOGETHER. THE COIL WAS SEPARATED FROM THE PUSHER AND DID NOT REMAIN IN THE PATIENT. THERE WAS NO INTERVENTION OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031287 ↗
• MalfunctionJun 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED IN THE MICROCATHETER. THE IMPLANT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER AND IT WAS FLUSHED OUT ON THE TABLE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028703 ↗
• MalfunctionNov 15, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076389 ↗
• MalfunctionJun 21, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL IN A SPLENIC ARTERY, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED INTO THE INTENDED AREA WITH A GUIDEWIRE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7625488 ↗