Azur Detachable Helical HydroCoil 45-451230Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810170015007), received between Mar 28, 2016 and Sep 16, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL IMPLANT WAS USED TO TREAT A PATIENT WITH AN UNRUPTURED ABDOMINAL INTERNAL ILIAC ARTERY ANEURYSM. THE COIL WAS DEPLOYED AS THIRD COIL VIA AN ANGIOGRAPHIC CATHETER WITHOUT THE USE OF A MICROCATHETER. DURING PLACEMENT OF THE THIRD COIL, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. DESPITE REPOSITIONING THE CATHETER, FURTHER ADVANCEMENT REMAINED IMPOSSIBLE. WHILE ATTEMPTING TO WITHDRAW, THE COIL PREMATURELY DETACHMENT IN ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS DISCONTINUED DUE TO THE INABILITY TO COMPLETE EMBOLIZATION. PRIOR TO THE DETACHMENT OF THIS COIL, TWO COILS OF THE SAME MODEL HAD ALREADY BEEN DEPLOYED FOR EMBOLIZATION. ANGIOGRAPHY CONFIRMED THAT THE EMBOLIZATION EFFECT HAD BEEN ACHIEVED AND NO ADDITIONAL COILS WERE IMPLANTED THEREAFTER. THE VASCULAR ANATOMY MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE COIL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065119 ↗
• MalfunctionAug 6, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ATTEMPTED DEPLOYMENT OF THE COIL THE COIL DETACHED PREMATURELY WHILE BEING RETRACTED BUT REMAINED INSIDE THE CATHETER. NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729105 ↗
• MalfunctionJan 2, 2024Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, DURING COIL ADVANCEMENT HALFWAY OUT OF THE CATHETER TIP, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE DEVICE WAS REPORTED TO BE INCOMPATIBLE WITH THE CATHETER AS RESISTANCE WAS REPORTED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432729 ↗
• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION THE COIL WAS DEPLOYED THROUGH A CATHETER IN A VEIN DURING A TIPSS PROCEDURE. THE COIL WAS DEPLOYED 1 TO 2 CENTIMETERS WHEN INCREASED FRICTION WAS NOTICED THEN IT WAS DISCOVERED THAT THE FILAMENT WAS BROKEN, AND THE COIL WAS DETECTED IN THE CATHETER. THE CATHETER WAS REMOVED WITH THE COIL IN IT AND A NEW CATHETER WAS USED TO FINISH THE EMBOLIZATION WITHOUT INCIDENT. THERE WAS NO PATIENT HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243474 ↗
• InjuryNov 4, 2022Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL WITHIN A RENAL VEIN FOR PELVIC CONGESTION, THE IMPLANT COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE COIL WAS PULLED AND STRETCHED AND UNRAVELED. THE COIL AND STRETCHED PORTION WAS SALVAGED AND COILED INTO THE APPROPRIATE VESSEL. AN ADDITIONAL COIL WAS PLACED BEHIND THE ORIGINAL COIL TO SECURE THE STRETCHED COIL. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724220 ↗
• MalfunctionAug 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, WHILE ADVANCING THE COIL IN A COMPETITOR MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED. THE COIL AND CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161530 ↗
• MalfunctionNov 21, 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 CONTROLLER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE CATHETER FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097847 ↗
• MalfunctionOct 18, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE COIL DID NOT ADVANCE PROPERLY IN THE MICROCATHETER. AFTER THE COIL HAD BEEN RETRACTED, AN ATTEMPT WAS MADE TO RE-ADVANCE THE COIL INTO THE MICROCATHETER, THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6960223 ↗
• MalfunctionMar 28, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED THAT DURING DURING THE TREATMENT OF AN ANEURYSM, THE COIL DETACHED PREMATURELY AFTER BECOMING STUCK WITHIN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE SUCCESSFULLY REMOVED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5530610 ↗