Azur Detachable Helical HydroCoil 45-480305Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810170017872), received between Oct 12, 2016 and May 21, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL PREMATURELY DETACHED. NO PATIENT HARM OR INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867725 ↗
• InjuryFeb 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING RETRACTION OF AN EMBOLIZATION COIL TO REPOSITION IT IN THE TREATMENT SITE, THE COIL UNEXPECTEDLY DETACHED. A CUT-DOWN WAS PERFORMED TO RETRIEVE THE DETACHED COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714818 ↗
• MalfunctionMay 3, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE TREATMENT OF A SMALL SEGMENT OF A HEPATIC ARTERY BRANCH, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL TO THE TARGET SITE. UNDER FLUOROSCOPIC GUIDANCE, IT WAS NOTED THAT THERE WAS NO COIL ON THE END OF THE WIRE. THE PUSHER WIRE WAS REMOVED; HOWEVER, THERE WAS NO COIL VISIBLE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579927 ↗
• MalfunctionApr 4, 2019Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL WAS NOT OPTIMALLY PLACED IN THE VESSEL. DURING AN ATTEMPT TO RETRACT THE COIL INTO THE CATHETER, IT WAS NOTED THE COIL HAD ALREADY DETACHED. THE COIL REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484342 ↗
• MalfunctionSep 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED WITHOUT USE OF THE V-GRIP CONTROLLER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885993 ↗
• MalfunctionMay 10, 2018Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT DURING POSITIONING OF THE 2ND EMBOLIZATION COIL IN THE MICROCATHETER, THE COIL DID NOT DETACH. A NEW CONTROLLER WAS USED;HOWEVER, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED INTO THE INTENDED AREA WITH A GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503636 ↗
• MalfunctionApr 5, 2018Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL, THE COIL DID NOT DETACH. THE PHYSICIAN WAS UNABLE TO RE-INTRODUCE THE COIL INTO THE SHEATH TO REMOVE IT FROM THE ARTERY. AS A RESULT, THE COIL WAS "FORCEFULLY" DETACHED. THE PROCEDURE WAS ABORTED. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401668 ↗
• MalfunctionOct 12, 2016Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT TREATMENT WAS BEING PERFORMED IN THE GASTRIC ARTERY. THE HYDROGEL COIL WAS EXTENDED OUT OF THE MICROCATHETER TO SOFTEN IT; HOWEVER, WHILE BRINGING IT BACK INTO THE MICROCATHETER, THE COIL DETACHED HALF IN AND HALF OUT OF THE MICROCATHETER. DURING WITHDRAWAL OF THE MICROCATHETER AND COIL FROM THE PATIENT, THE COIL BECAME STUCK IN THE 5 FR. FEMORAL INTRODUCER SHEATH. THE SHEATH, MICROCATHETER, AND COIL IN ITS ENTIRETY WERE REMOVED TOGETHER AS A SINGLE UNIT FROM THE PATIENT. FEMORAL ACCESS WAS THEN GAINED IN THE LEFT FEMORAL ARTERY TO PERFORM THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6022890 ↗