Azur Detachable Helical HydroCoil 45-480202Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810170017841), received between Feb 24, 2017 and Mar 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 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.

• MalfunctionMar 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE AZUR 18 DETACHABLE EMBOLIZATION COIL WAS USED TO TREAT A LEFT ILIOLUMBAR ARTERY. WHILE MANIPULATING THE AZUR 18 COIL, THE PHYSICIAN INADVERTENTLY PULLED BACK INTO THE MICROCATHETER AN AZUR CX 18 COIL THAT HAD BEEN PREVIOUSLY DETACHED. REPORTEDLY, THE AZUR18 WAS UNINTENTIONALLY DETACHED IN THE MICROCATHETER AND MULTIPLE ATTEMPTS WITH VARIOUS WIRES TO PUSH BOTH COILS OUT WERE UNSUCCESSFUL. THE MICROCATHETER AND AZUR 18 COIL WERE REMOVED FROM THE PATIENT ALONG WITH THE AZUR CX 18 THAT WAS STILL IN THE DISTAL END OF THE MICROCATHETER. NO ADDITIONAL INTERVENTION WAS NEEDED AS MUCH TIME HAD PASSED WHILE ATTEMPTING TO CORRECT THE SITUATION THAT THE ARTERY OCCLUDED WITH THE FIRST COIL LEFT IN. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981190 ↗
• MalfunctionJun 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING TREATMENT OF A UTERINE FIBROID, AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY. HOWEVER, THE IMPLANT COIL WAS ABLE TO BE DELIVERED SAFELY TO TREAT THE FIBROID. THE EMBOLIZATION PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17120160 ↗
• MalfunctionMar 30, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A GI BLEED, THE EMBOLIZATION COIL WOULD NOT DETACH WITH MULTIPLE ATTEMPTS OR DETACHMENT CONTROLLERS. IT WAS DECIDED TO WITHDRAW THE DEVICE WITH APPROXIMATELY ONE QUARTER OF THE COIL INTO THE CATHETER, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE CATHETER WAS FLUSHED WITH SALINE AND CONTRAST TO FLUSH THE COIL TO DEPLOY AT THE TREATMENT SITE. THE CASE WAS COMPLETED. THE PATIENT IS REPORTED SABLE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16651990 ↗
• MalfunctionJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER WHEN IT WAS PARTIALLY PUSHED OUT INTO THE ANEURYSM. THE COIL WAS THEN PUSHED OUT OF CATHETER USING GUIDEWIRE AND WAS IMPLANTED IN THE ANEURYSM. OTHER COILS HAD BEEN PUSHED THROUGH AND DEPLOYED THROUGH SAME MICROCATH WITH NO ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT OF HARM ON INJURY TO THE PATIENT, WHO WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359702 ↗
• MalfunctionJun 19, 2020Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT IN THE TREATMENT SITE, THE COIL WOULD NOT TAKE SHAPE. DURING RETRACTION OF THE DEVICE, THE IMPLANT COIL DETACHED FROM THE PUSHER WIRE. THE IMPLANT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT'S CONDITION IS REPORTED TO BE "STABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10177045 ↗
• MalfunctionApr 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL UNEXPECTEDLY DETACHED WITHOUT USE OF THE CONTROLLER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960273 ↗
• MalfunctionJul 23, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS BEING PERFORMED TO OCCLUDE AN AORTO-PULMONARY COLLATERAL COMING OFF THE INNOMINATE ARTERY TO THE RIGHT PULMONARY ARTERY. AFTER POSITIONING THE COIL AT THE TREATMENT SITE IN THE COLLATERAL, THE COIL WOULD NOT DETACH. DURING AN ATTEMPT TO REMOVE THE COIL, THE DELIVERY PUSHER WIRE BECAME STUCK AND THEN THE DISTAL END OF THE PUSHER WIRE BROKE/DETACHED, ALTHOUGH IT WAS STILL ATTACHED TO THE IMPLANT COIL. THE DETACHED PORTION OF THE PUSHER WIRE WAS SUCCESSFULLY PUSHED INTO THE COLLATERAL WITH THE IMPLANT AND THE COLLATERAL WAS COMPLETELY OCCLUDED, AS DESIRED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE CURRENT CONDITION OF THE PATIENT IS REPORTED TO BE "WITHIN NORMAL LIMITS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818236 ↗
• MalfunctionFeb 24, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE TREATING AN ANGIOMYOLIPOMA IN THE KIDNEY. THE MD USED A PROGREAT 2.8 WITH A FRAMING COIL 14X35, HE THEN REQUESTED THE BIGGEST HYDROCOIL AVAILABLE 20X30. THE PROGREAT HAD A HAIR PIN TURN ALMOST FOLDING ON ITSELF. THE ANATOMY WAS VERY TORTUOUS AND THE HYDROCOIL UNEXPECTEDLY DETACHED IN THE CATHETER. THE PROGREAT AND COIL WERE REMOVED AND A SMALLER HYDROCOIL WAS DEPLOYED WITH NO ISSUES. NO INJURY WAS REPORTED. THE PATIENT'S CONDITION IS SAID TO BE "FINE". THE PROCEDURE OUTCOME WAS SUCCESSFUL, THE MICROCATHETER WAS REMOVED AND THE COIL WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6355657 ↗