Azur Detachable Helical HydroCoil 45-480420Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00810170017926), received between Feb 16, 2016 and Jul 29, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT A COMPETITOR BASE CATHETER, THEN A 2.4 MICROCATHETER CATHETER WAS USED IN THE CELIAC THEN GDA. PUSHED COIL THROUGH CATHETER, AFTER PLACING 2 COMPETITOR COILS. THE COIL OF CONCERN GOT HUNG UP IN THE CATHETER AND PREMATURELY DETACHED. WAS ABLE TO REVERSE SUCTION COIL PARTWAY INTO THE MICROCATHETER THEN PULL THE MICROCATHETER INTO THE BASE CATHETER AND REVERSE SUCTION AND PULL THE BASE CATHETER OUT WITH THE COIL. NO HARM TO PATIENT. ENDED UP USING GELFOAM EMBOLIC AGENT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22657102 ↗
• MalfunctionApr 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A VENOUS COLLATERAL EMBOLIZATION. AFTER PLACING MULTIPLE COILS, THIS HYDRO COIL WAS SELECTED, WHICH WAS PREPPED AS NORMAL AND WAS INTRODUCED INTO THE MICROCATHETER WITHOUT INCIDENT. AS THE PHYSICIAN WAS DEPLOYING THE COIL, IT GOT STUCK ABOUT 1/3 OF THE WAY OUT OF THE MICROCATHETER. THE PHYSICIAN TRIED TO RETRACT AND THE COIL PREMATURELY DEPLOYED INSIDE THE CATHETER. PHYSICIAN WAITED ABOUT 5-8 MINUTES FOR THE HYDRO TO EXPAND AND TOOK COIL AND MICROCATHETER OUT TOGETHER. THE PHYSICIAN WAS ABLE TO REINTRODUCE THE CATHETER AND FINISHED CASE WITHOUT INCIDENT. THE EMBOLIZATION PROCEDURE WAS SUCCESSFUL WITHOUT REPORT OF HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159192 ↗
• MalfunctionAug 16, 2023Premature Separation; Premature Separation

  SEE H.10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560983 ↗
• MalfunctionSep 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHEN ADVANCING THE COIL IMPLANT IN THE MICROCATHETER AND THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT AND PROCEDURE COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502226 ↗
• MalfunctionAug 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND PROCEDURE COMPLETED USING OTHER COILS. OUTCOME WAS SUCCESSFUL AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254570 ↗
• MalfunctionNov 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL PREMATURELY DETACHED PRIOR TO USING THE DETACHMENT CONTROLLER. NO HARM OR SECONDARY INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842116 ↗
• MalfunctionJun 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION OF THE GASTRODUODENAL ARTERY, RESISTANCE WAS ENCOUNTERED AS THE LAST 5CM WAS BEING DEPLOYED. THE PHYSICIAN BELIEVED THE VESSEL MAY HAVE BEEN SMALLER IN THAT AREA. UPON PUSHING HARDER, THE COIL DETACHED ON ITS OWN IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER ALONG WITH THE COIL, SAFELY REMOVING ALL PARTS. THE CASE PROCEEDED WITH NO FURTHER ISSUES. NO INTERVENTION OR PATIENT INJURY WAS REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029469 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PERIPHERAL COIL EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL WOULD NOT ADVANCE AND THEN DETACHED DURING THE REMOVAL ATTEMPT. 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 10906628 ↗
• MalfunctionFeb 14, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL DID NOT COMPLETELY DETACH AND THEN UNEXPECTEDLY DETACHED DURING WITHDRAWAL OF THE PUSHER WIRE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714873 ↗
• 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 8586910 ↗
• MalfunctionFeb 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GASTRODUODENAL ARTERY EMBOLIZATION TREATMENT FOR A GASTROINTESTINAL BLEED, THE COIL DETACHED INSIDE THE CATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH 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 8346202 ↗
• MalfunctionAug 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED PARTIALLY IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827516 ↗
• MalfunctionJul 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF A SPLENIC ARTERY, THE COIL WAS LEFT IN THE ARTERY FOR APPROXIMATELY THREE (3) MINUTES PRIOR TO MAKING THE DECISION TO DEPLOY. THE COIL CONTINUED TO GET SUCKED INTO THE DEFECT, SO AN ATTEMPT WAS MADE TO REMOVE THE COIL. DURING REMOVAL, THE COIL DETACHED IN THE CATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7666672 ↗
• MalfunctionMar 23, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED IN THE MICROCATHETER WHILE PLACING THE COIL IN THE ANEURYSM. DURING AN ATTEMPT TO REMOVE THE COIL, THE COIL DETACHED FROM THE PUSHER WIRE IN THE MICROCATHETER. THE COIL WAS PUT INTO THE ANEURYSM WITH THE PUSHER WIRE AND REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7368170 ↗
• MalfunctionMar 2, 2018Detachment Of Device Component; Difficult To Position; Device-Device Incompatibility; Detachment Of Device Component; Difficult To Position; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO PLACE THE COIL DURING A RENAL EMBOLIZATION PROCEDURE, THE COIL WAS RETRACTED; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED ALONG WITH THE MICROCATHETER FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7311387 ↗
• MalfunctionNov 15, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE COIL WIRE APPEARED TO HAVE A BREAK BEFORE THE ACTUAL COIL, AND WOULD NOT ADVANCE IN THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035629 ↗
• MalfunctionSep 15, 2016Detachment Of Device Component; Difficult to Advance; Detachment Of Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING TREATMENT OF THE HEPATIC ARTERY, A SMALL PORTION OF THE COIL EXITED THE MICROCATHETER. THE COIL WAS THEN ADVANCED WITH SOME DIFFICULTY. THE COIL DETACHED IN THE MICROCATHETER WITHOUT USE OF THE CONTROLLER. THE DETACHED COIL WAS PUSHED OUT OF THE MICROCATHETER WITH THE PUSHER WIRE. THE COIL REMAINS IN THE INTENDED SITE OF TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5953039 ↗
• MalfunctionSep 15, 2016Detachment Of Device Component; Difficult to Advance; Detachment Of Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING TREATMENT OF THE HEPATIC ARTERY, A SMALL PORTION OF THE COIL EXITED THE MICROCATHETER. THE COIL WAS THEN ADVANCED WITH SOME DIFFICULTY. UPON EXITING THE MICROCATHETER, THE COIL WAS FOUND TO HAVE DETACHED WITHOUT USE OF THE CONTROLLER. THE DETACHED COIL REMAINS IN THE INTENDED SITE OF TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5952830 ↗
• MalfunctionFeb 16, 2016Detachment Of Device Component; Activation, Positioning or Separation Problem; Detachment Of Device Component; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL PREMATURELY DETACHED OR BROKE WITHIN THE MICROCATHETER. THE DEVICES WERE REPORTED DISCARDED. NO HARM OR INJURY OCCURRED AS A RESULT OF THIS INCIDENT. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Aneurysm; No Consequences Or Impact To Patient

  MAUDE report 5439374 ↗