Azur Detachable Helical HydroCoil 45-452030Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810170015045), received between Jul 7, 2017 and Sep 1, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COILING OF PSEUDO ANEURYSM OF THE PULMONARY ARTERY, THE COIL DETACHED EARLY INSIDE THE CATHETER WHILE BEING INSERTED. THE COIL WAS ABLE TO BE REMOVED FROM THE CATHETER BY REMOVING THE ENTIRE CATHETER FROM BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MORE COILS. THERE WAS NO PATIENT INJURY AND NO NEED FOR MEDICAL INTERVENTION, PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674021 ↗
• InjuryNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL IMPLANT IN THE LEFT ATRIAL APPENDAGE, THE IMPLANT WAS NOT COILING PROPERLY. THE PHYSICIAN INCREASED THE TORQUE ON THE DEVICE AND THE IMPLANT DETACHED UNEXPECTEDLY. THE COIL WAS PARTIALLY WITHIN THE CATHETER AND A SNARE WAS USED TO REMOVE IT. THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE" AND THE OUTCOME OF THE PROCEDURE WAS REPORTED TO BE "SUCCESSFUL." THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749305 ↗
• MalfunctionFeb 13, 2021Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL DID NOT DETACH AND DURING REMOVAL, THE EMBOLIZATION COIL DETACHED IN THE CATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325948 ↗
• MalfunctionMar 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A TYPE 1 ENDOLEAK. AFTER PLACEMENT OF 5 EMBOLIZATION COILS, THE 6TH COIL UNEXPECTEDLY DETACHED DURING REPOSITIONING. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9855677 ↗
• MalfunctionDec 20, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WOULD NOT ADVANCE MORE THAN 2 CM OUT OF THE TIP OF A SUPPORT CATHETER DURING TREATMENT OF AN ABDOMINAL ANEURYSM. THE COIL WAS RETRACTED BACK INTO THE CATHETER AND ADVANCED AGAIN, BUT NO MORE THAN 2CM OF THE COIL WOULD EXIT THE CATHETER TIP. WHILE ATTEMPTING TO REMOVE THE COIL, THE COIL DETACHED IN THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508098 ↗
• MalfunctionSep 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL BECAME DETACHED PREMATURELY DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132206 ↗
• MalfunctionMay 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED IN THE CATHETER. 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 8622149 ↗
• MalfunctionAug 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL, IT WAS NOTED THAT THE COIL WAS NO LONGER ATTACHED TO THE PUSHER WIRE AND STOPPED ADVANCING. DURING REMOVAL OF THE PUSHER WIRE, THE COIL DETACHED INSIDE THE CATHETER. A SYRINGE WAS USED TO ASPIRATE THE COIL BACKWARDS INTO THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801845 ↗
• MalfunctionDec 14, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, AN EMBOLIZATION COIL GOT STUCK IN A 5F CATHETER DURING ADVANCEMENT INTO A GASTRIC VARICE. AN ATTEMPT WAS MADE TO ADVANCE THE COIL AGAINST RESISTANCE, FOLLOWED BY COIL WITHDRAWAL AND ANOTHER ATTEMPT TO ADVANCE THE COIL OUT OF THE CATHETER, AT WHICH TIME THE COIL DETACHED IN THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE CATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7119429 ↗
• MalfunctionJul 7, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A COIL EMBOLIZATION WAS PERFORMED VIA DIRECT STICK INTO THE ANEURYSM SAC. DURING THE PROCEDURE, THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER, WHILE PART OF THE COIL WAS POSITIONED IN THE SAC. AN ATTEMPT WAS MADE TO FLUSH THE COIL OUT OF THE CATHETER WITH SALINE; HOWEVER, IT WAS UNSUCCESSFUL. DURING REMOVAL OF THE CATHETER, PART OF THE COIL WAS LEFT BEHIND IN THE ACCESS TRACK. THERE WAS NO REPORTED INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT PATIENT'S STATUS IS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693691 ↗