Azur Detachable Helical HydroCoil 45-451530Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810170015021), received between Mar 18, 2017 and Dec 21, 2023 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Premature Separation; Premature Separation

  AS REPORTED, THE EMBOLIZATION COIL WAS USED DURING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WHERE THE VARICES WERE COILED. REPORTEDLY, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER DURING DEPLOYMENT. THE CATHETER AND COIL WERE SAFELY REMOVED FROM THE PATIENT AND EXCHANGED FOR A NEW SET AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT WAS STABLE AND WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375519 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE OF A PELVIC CONGESTIVE VEINS. A COIL WAS PLACED IN THE LEFT OVARIC VEIN. TO FINALIZE THE PROCEDURE, ANOTHER COIL PLACED AND PUSHED INTO THE CATHETER, THREE LOOPS WERE CONFORMED WHEN. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE, TRIED TO PUSH THE COIL WITH NO COIL RESPONSE THEN TRIED TO RECOVER THE COIL TO CHECK. WHILE RETRIEVING THE COIL IT WAS OBSERVED THAT THE COIL DELIVERY SYSTEM WAS BROKEN, AND COIL DELIVERED INTO THE CATHETER. THE COIL WAS ANKLE TO THE OVARIC VEIN BUT JUMPED IN THE CAVA VEIN. COIL WAS SUCCESSFULLY RETRIEVED WITH A SNARE. NO REPORTED INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253124 ↗
• MalfunctionNov 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION FOR A VARICOCELE, THE EMBOLIZATION COIL WAS ADVANCED WITH ADDITIONAL FORCE AND THE COIL DETACHED IN THE MICROCATHETER. THE WIRE WAS USED TO PUSH THE IMPLANT COIL INTO THE TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10807063 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A PERIPHERAL ARTERY ANEURYSM, THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731358 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A PERIPHERAL ARTERY ANEURYSM, THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731324 ↗
• MalfunctionJun 4, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL DETACHED IN THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567916 ↗
• MalfunctionMar 18, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT FOR AN ENDOLEAK, THE COIL UNEXPECTEDLY DETACHED WITHOUT USE OF THE CONTROLLER. THE POSITION OF THE COIL WAS DEEMED SATISFACTORY AND LEFT IN THE ANEURYSM. NO INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6416042 ↗