Azur Detachable Helical HydroCoil 45-450820Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810170014956), received between Mar 18, 2017 and Apr 1, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment Of 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Packaging Problem; Packaging Problem

  AS REPORTED: THE REPRESENTATIVE PULLED A HYDROCOIL OUT OF THE BOX PRIOR TO A CASE. THE HYDROCOIL PACKAGE HAD A RED REJECTED STICKER ON THE BACK OF THE COIL PLASTIC PACKING. THERE WAS NO OTHER STICKER OR LABEL NOTED ON THE BOX OR EXTERIOR PACKAGING OF THE COIL. NO OTHER PACKAGES WERE FOUND WITH A SIMILAR STICKER. THE STERILE PLASTIC PACKING WAS INTACT. THE COIL WAS NEVER PRESENTED TO A CUSTOMER OR USED WITH A PATIENT, NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015160 ↗
• MalfunctionFeb 17, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMERGENCY EMBOLIZATION TREATMENT FOR A PEPTIC ULCER , THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL FROM AN UNDESIRABLE LOCATION, AND IT PREMATURELY DETACHED. THE COIL WAS ABLE TO BE POSITIONED CORRECTLY AND WAS IMPLANTED IN THE ARTERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397636 ↗
• MalfunctionApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR PELVIC CONGESTION, WHEN TRYING TO RETRACT AN EMBOLIZATION IMPLANT COIL THROUGH THE CATHETER TO REPOSITION, THE IMPLANT DETACHED. THE CATHETER AND COIL WERE SUCCESSFULLY REMOVED FROM THE PATIENT TOGETHER. NO PATIENT INJURY OR INTERVENTION WAS REPORTED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611049 ↗
• MalfunctionJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A SPLENIC ANEURYSM, THE COIL DETACHED FROM THE PUSHER WIRE AFTER APPROXIMATELY HALF OF THE IMPLANT COIL HAD BEEN PLACED IN THE ANEURYSM. THE PUSHER WAS REMOVED FROM THE CATHETER AND NEGATIVE PRESSURE WAS APPLIED TO THE IMPLANT COIL AS IT WAS REMOVED SIMULTANEOUSLY WITH THE CATHETER FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719297 ↗
• InjuryMay 7, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGICAL INTERVENTION DUE TO COIL MIGRATION, TO SURGICALLY REMOVE A PREVIOUSLY IMPLANTED COOK STENT ZILVER OR COIL FRAGMENTS. IN THE AFTERNOON OF (B)(6) 2017, THE PATIENT CALLED THE PHYSICIAN COMPLAINING OF SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE PHYSICIAN DIRECTED THE PATIENT TO PRESENT HIMSELF TO THE (B)(6) MEDICAL CENTER EMERGENCY ROOM. AT THE EMERGENCY ROOM, DOCTORS PERFORMED A BATTERY OF TESTS AND SCANS. TESTS SHOWED THAT THE COOK BILIARY STENT AND TERUMO AZUR COIL DR. (B)(6) HAD PREVIOUSLY IMPLANTED HAD FAILED. INSTEAD OF STAYING IN PLACE, THE ZILVER STENT AND COIL HAD MOVED AND WERE OBSTRUCTING HIS RIGHT ATRIUM, THE RIGHT-HAND SIDE OF HIS HEART. TO BE SURE, ONE OF THE STENT'S COILS THAT WAS IN HIS PELVIS WAS NOW IN A TERTIARY PULMONARY ARTERY ON THE RIGHT SIDE OF THE PATIENT'S HEART FURTHERMORE, AN X-RAY SHOWED THAT THERE WAS A COIL IN THE PATIENT'S RIGHT LUNG. DR. (B)(6) ELECTED TO REMOVE THE FAILED STENT AND AZUR COIL. THE PATIENT WAS SUBJECTED TO ANESTHESIA AND A LENGTHY PROCEDURE TO REMOVE THE STENT AND COIL DEBRIS. AFTER THE PROCEDURE, THE PATIENT WAS SENT TO THE ICU FOR OBSERVATION. THE FOLLOWING MORNING, A CT SCAN SHOWED

  Patient problems: Chest Tightness/Pressure; Vascular System (Circulation), Impaired

  MAUDE report 8586908 ↗
• MalfunctionJun 27, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL DETACHED IN THE MICROCATHETER WITHOUT USE OF THE CONTROLLER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643612 ↗
• MalfunctionMay 19, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE REPOSITIONING THE LAST OF 6 COILS, THE COIL UNEXPECTEDLY DETACHED WITHOUT USE OF THE CONTROLLER. THE CASE FINISHED WELL. NO INTERVENTION OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6579489 ↗
• InjuryMar 18, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF AN AZUR EMBOLIZATION COIL, THE COIL UNEXPECTEDLY DETACHED WITHOUT USE OF THE CONTROLLER. THE COIL WAS RETRIEVED WITH A SNARE DEVICE. THE PATIENT WAS IMPLANTED WITH OTHER AZUR COILS SUCCESSFULLY, WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6416043 ↗