Azur CX Detachable 45-781238Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00810170018367), received between Feb 20, 2017 and Jun 6, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2026Stretched; Premature Separation

  AS REPORTED: DURING ADVANCEMENT OF THE COIL THROUGH A PROGREAT MICROCATHETER, RESISTANCE WAS ENCOUNTERED. THE DOCTOR ATTEMPTED TO REMOVE THE COIL, BUT IT DETACHED WITHIN THE PROGREAT. THE DOCTOR THEN FLUSHED THE COIL TO THE DESIRED TARGET LOCATION AND REMOVED THE DELIVERY WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THIS REPORT ADDRESSES THE SECOND COIL. THE FIRST COIL IS REFERENCED UNDER MFR REPORT #2032493-2026-00365.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418359 ↗
• MalfunctionSep 14, 2025Premature Separation; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048166 ↗
• MalfunctionJun 7, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT SPONTANEOUS COIL DEPLOYMENT OCCURRED IN THE VESSEL LUMEN BEFORE PLACEMENT IN THE TARGET VESSEL. THERE WAS NO DETACHMENT OR REPOSITIONING OF THE COIL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163825 ↗
• MalfunctionMay 5, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL BROKE IN THE MICROCATHETER WHEN TRYING TO REPLACE IT. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962212 ↗
• MalfunctionDec 4, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY WITHIN THE MICROCATHETER. THE IMPLANT WAS REMOVED WITH THE MICROCATHETER AND NOT IMPLANTED. THE CASE WAS COMPLETED WITH OTHER COIL IMPLANTS. THERE WAS NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848293 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: 64 YEAR OLD MAN WITH HISTORY OF A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) STENT PLACED ONE WEEK PRIOR PRESENTED WITH IN-STENT THROMBOSIS AND ESOPHAGEAL VARIX. DURING ESOPHAGEAL VARIX EMBOLIZATION, RIGHT IJ ACCESS WAS OBTAINED WITH A 10F TIPS SHEATH. A 120CM TAPERED GLIDECATH WAS ADVANCED THROUGH THE 10F SHEATH TO JUST PROXIMAL TO THE ESOPHAGEAL VARIX. DUE TO SOME MILD TORTUOSITY JUST PROXIMAL TO THE VARIX, A 2.8F PROGREAT WAS TELESCOPED THROUGH THE GLIDECATH TO ACCESS THE VARIX. GELFOAM WAS INJECTED INTO THE DISTAL PORTION OF THE VARIX AND THE MICROCATHETER WAS FLUSHED COPIOUSLY WITH SALINE. FOLLOWING PROPER BACK TABLE PREP AND FLUSH, AN AZUR 10X32 018CX COIL WAS LOADED AND DELIVERED THROUGH A 2.8F 150CM PROGREAT. THE MICROCATHETER WAS FLUSHED, THEN AN AZUR 12X38 018 CX WAS PREPPED AND LOADED INTO THE SAME SYSTEM. THIS COIL TRAVELED SMOOTHLY THROUGH THE PROGREAT UNTIL IT REACHED THE DISTAL TIP. THE COIL WOULD NOT ADVANCE PAST THE DISTAL TIP OF THE MICROCATHETER AND WAS REMOVED. THE MICROCATHETER SYSTEM WAS FLUSHED AGAIN, AND ANOTHER AZUR 12X38CM 018CX WAS LOADED INTO THE 2.8F PROGREAT. THIS COIL EXPERIENCED RESISTANCE IN THE DISTAL THIRD OF THE MICROCAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762454 ↗
• MalfunctionJul 15, 2024Premature Separation; Premature Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19743028 ↗
• InjuryMar 26, 2024Premature Separation; Premature Separation

  SEE H.10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981241 ↗
• MalfunctionApr 24, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. NO PATIENT HARM OR CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16803082 ↗
• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL IMPLANT ENCOUNTERED ISSUES WHEN LOADING INTO THE MICROCATHETER AND UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. ANOTHER COIL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. PATIENT REPORTED TO BE "STABLE."IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE DURING INSERTION AND ADVANCING INTO THE MICROCATHETER AND UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT AND OTHER COILS OF THE SAME TYPE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. PATIENT REPORTED TO BE "STABLE." THIS IS REPORT 4 OF 4. REFERENCE MFR. REPORTS#: 2032493-2021-00246, 2032493-2021-00247, AND 2032493-2021-00248.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037998 ↗
• MalfunctionApr 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL DETACHED FROM THE DELIVERY PUSHER PRIOR TO DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683133 ↗
• InjuryNov 20, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM TO TREAT A TYPE II ENDOLEAK, THE EMBOLIZATION COIL WOULD NOT ADVANCE AND THEN DETACHED PARTIALLY IN THE ANEURYSM. THE COIL WAS SUCCESSFULLY SNARED FROM THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10880803 ↗
• MalfunctionOct 21, 2019Therapeutic or Diagnostic Output Failure

  UNABLE TO THREAD INTO CATHETER AFTER MULTIPLE ATTEMPTS BY COMPETENT RAD TECHS AND PHYSICIANS IN A VERY CRITICAL, BLEEDING PT. ATTEMPTED WITH TWO CATHETERS OF THIS SIZE. SIX DIFFERENT COILS ATTEMPTED WITH MALFUNCTION. ANOTHER PRODUCT USED TO STABILIZED THE PT. TWO COILS SUCCESSFULLY USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9219304 ↗
• MalfunctionApr 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 MICROCATHETER. 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 8525483 ↗
• MalfunctionFeb 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AN AZUR EMBOLIZATION COIL WAS IMPLANTED IN THE SPLENIC ARTERY, AND OTHER COILS (NOT MV) WERE IMPLANTED AFTERWARD. THE DEPLOYMENT WENT WELL AND THE AZUR COIL APPEARED TO BE UNIFORMLY SHAPED IN THE VESSEL; HOWEVER, APPROXIMATELY 8 MINUTES AFTER IMPLANTATION, THE COIL MIGRATED DISTALLY. THERE WERE NO NEGATIVE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6342644 ↗