Azur Detachable Helical HydroCoil 45-480415Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810170017919), received between Jan 16, 2019 and May 4, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2023Premature Separation; Premature Separation

  IT WAS REPORTED DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE COIL INSIDE THE MICROCATHETER AND ATTEMPTED TO FORM A SECOND LOOP, BUT IT WAS UNSUCCESSFUL. WHEN THE COIL WAS RETRACTED TO BE READJUSTED, IT PREMATURELY DETACHED. THE COIL, MICROCATHETER, AND GLIDE CATHETER WERE ALL REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY OR INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873740 ↗
• MalfunctionAug 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING A 2.8MM A GASTRODUODENAL ARTERY (GDA) ANEURYSM AND WAS GIVEN AN AZUR HYDRO COIL INSTEAD OF AN AZUR CX BY A NEW TECHNICIAN. THE PHYSICIAN PUSHED THE FIRST LOOP OUT JUST FINE AND THEN THE COIL JUST CAME OUT STRAIGHT. THE PHYSICIAN PAUSED FOR 15-30 SECONDS TO LET THE COIL SOFTEN AND ATTEMPTED TO PUSH THE COIL OUT OF THE MICROCATHETER AGAIN. THIS TIME IT PUSHED THE MICROCATHETER BACK AND PHYSICIAN TRIED TO TRACK THE CATHETER OVER THE COIL WHEN A POP WAS FELT, AND THE COIL BROKE OFF OF THE PUSHER WIRE. THE PHYSICIAN THEN PULLED THE MICROCATHETER AND COIL OUT AND WAS ABLE TO REMOVE THE COIL FROM THE MICROCATHETER ON THE BACK TABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING OTHER AZUR CX COILS, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192342 ↗
• MalfunctionAug 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT, THE PUSHER WIRE BROKE FROM THE COIL WHILE REPOSITIONING. THE COIL AND THE COMPETITOR MICROCATHETER WERE REMOVED FROM THE PATIENT. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164007 ↗
• InjuryNov 17, 2021Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  IT WAS REPORTED THAT DURING TREATMENT OF A GASTRIC PSEUDOANEURYSM, AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY WITHIN THE MICROCATHETER DURING POSITIONING. A GLIDEWIRE WAS USED TO PUSH THE IMPLANT INTO THE PSEUDOANEURYSM. ON FLUOROSCOPY THE IMPLANT WAS NOTICED TO HAVE STRETCHED FROM THE TREATMENT SITE DOWN TO THE HEPATIC ARTERY. THE PATIENT'S CONDITION REPORTED TO BE STABLE AND PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830039 ↗
• MalfunctionJul 30, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE EMBOLIZATION TREATMENT OF A SPLENIC ARTERY, RESISTANCE WAS ENCOUNTERED BETWEEN THE CATHETER AND THE EMBOLIZATION COIL AND THE ANATOMY WAS REPORTED TO BE DIFFICULT WITH MANY CURVES. THE COIL WAS REPORTED TO HAVE DETACHED FROM THE DELIVERY PUSHER. THE COIL AND MICROCATHETER WERE REMOVED TOGETHER AS A SYSTEM. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250835 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL DETACHED INSIDE THE MICROCATHETER. THE COIL AND THE MICROCATHETER WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT'S CONDITION IS REPORTED TO BE "STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10554171 ↗
• InjuryJan 16, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COIL DETACHED IN THE PROXIMAL PORTION OF THE VESSEL. 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 8255414 ↗