AZUR 45-880050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842429118078), received between Aug 10, 2024 and May 29, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Premature Separation

  IT WAS REPORTED THAT CUSTOMER STATES COIL DETACHED WITHOUT PROPERLY USING PICKLE. THE DEVICE IMPLANTED AND DETACHED SAFELY INTO THE PATIENT. NO COMPLICATIONS AND PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340362 ↗
• InjuryMar 20, 2026Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION CASE, A CATHETER WAS ADVANCED TO THE TARGET AREA. PRIOR COILS WERE INSERTED AND SUCCESSFULLY DEPLOYED AT THE TARGET AREA. THE COIL IN QUESTION ADVANCED IN THE CATHETER, AND ABOUT 2 CENTIMETERS OF THE COIL CAME OUT OF THE DISTAL END OF THE CATHETER. IT WAS DECIDED TO RETRACT THE COIL INTO THE CATHETER. AT THIS TIME, IT WAS DISCOVERED THE DELIVERY DEVICE HAD BECOME DISCONNECTED FROM THE COIL. IT WAS DECIDED BY THE PHYSICIAN TO PUSH THE COIL WITH THE DELIVERY DEVICE. THE COIL FULLY DEPLOYED INSIDE THE PATIENT, BUT NOT AT TARGET AREA. THE CATHETER WAS REMOVED. A SNARE OF UNKNOWN SIZE WAS INSERTED FOR COIL REMOVAL, AND THE COIL BROKE INSIDE OF THE PATIENT UPON ATTEMPTING TO SNARE. PARTS OF THE COIL WERE REMOVED FROM THE PATIENT WITH THE SNARE. IT WAS NOTED BY THE PHYSICIAN THAT PIECES OF THE COIL WERE STILL INSIDE THE PATIENT. IT IS UNKNOWN THE AMOUNT OF THE COIL RETRIEVED OR AMOUNT OF THE COIL REMAINING IN PATIENT. THE PATIENT WAS REPORTED TO BE STABLE, AS PER THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656141 ↗
• InjuryMar 13, 2026Premature Separation

  AS REPORTED: WAS TOLD THAT THE COIL DETACHED PREMATURELY. DOCTOR ENDED UP HAVING TO USE A SNARE TO REMOVE THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599062 ↗
• MalfunctionDec 18, 2025Premature Separation; Premature Separation

  AS REPORTED: COIL SEPARATED IN CATHETER PER PERIOP NURSE, FAILED DEPLOYMENT. COIL WAS PULLED OUT WITH MICROCATHETER. CASE COMPLETED USING ANOTHER COIL OF SIMILAR SIZE. NO PATIENT INJURY REPORTED. TYPE OF PROCEDURE PERFORMED: PELVIC CONGESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840134 ↗
• InjuryNov 12, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT DURING AN AORTIC COLLATERAL ARTERY EMBOLIZATION MULTIPLE COILS WERE USED PRIOR TO THE CONCERNED COIL BEING PLACED. THE 50CM COIL WAS PLACED THROUGH A 2.8F MICROCATHETER, WHICH WAS ADVANCED THROUGH A 4F INTERMEDIATE CATHETER. THE INTERMEDIATE CATHETER WAS IN THE OSTIUM OF A COLLATERAL VESSEL OFF THE ABDOMINAL AORTA. AFTER A DIFFICULT ADVANCEMENT OF THE CONCERNED COIL INTO THE TARGET VESSEL, THE COIL DETACHMENT WAS ATTEMPTED USING A DETACHMENT CONTROLLER. AFTER TWO DEPLOYMENT CYCLES TO DETACH THE COIL, THE PHYSICIAN THOUGHT THE COIL WAS DETACHED; HOWEVER, THE COIL CAME BACK A LITTLE. THE PHYSICIAN ADVANCED THE COIL BACK INTO THE VESSEL WHERE MOST OF THE 50CM WAS COILED INTO. WHEN REPOSITIONING THE COIL IT DETACHED ON ITS OWN AND A TALE OF THE COIL WAS IN THE AORTA. ATTEMPT TO TUCK THE END INTO THE VESSEL WITH THE CATHETER TIP AND A WIRE WAS UNSUCCESSFUL. THE PHYSICIAN THEN USED A 10 GOOSENECK SNARE TO REMOVE THE COIL. WHILE REMOVING THE COIL THROUGH THE CATHETER IT STARTED TO STRING OUT. THE PHYSICIAN SLOWLY PULLED ON THE COIL/WIRE AND SUCCESSFULLY REMOVED THE WHOLE COIL. MULTIPLE OTHER COILS WERE USED IN THIS PROCEDURE IN MULTIPLE DIFFERENT LOCATIONS. THE CASE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538342 ↗
• MalfunctionNov 7, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE IN THE MICROCATHETER. THE COIL BROKE OFF IN THE CATHETER. THE COIL AND CATHETER WERE REMOVED FROM THE PATIENT. A NEW CATHETER WAS INSERTED. THE PROCEDURE WAS A SUCCESS. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503631 ↗
• MalfunctionSep 13, 2025Premature Separation; Premature Separation

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION RECEIVED: THE PARENCHYMAL TRACT WAS SUCCESSFULLY EMBOLIZED AND THE PROCEDURE WAS SUCCESSFUL. SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047552 ↗
• InjuryJan 15, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHILE A COIL WAS BEING DELIVERED DURING A COIL EMBOLIZATION PROCEDURE, IT ADVANCED INTO A SMALL BRANCH JUST PROXIMAL TO THE TARGET LANDING ZONE. THE COIL WAS ATTEMPTED TO BE RECAPTURED, BUT IT PREMATURELY DETACHED. UPON FURTHER PULLING BACK THE PUSHER WIRE, THE COIL WAS FOUND DETACHED WITHIN THE 4FR GLIDE CATHETER. A .025 WIRE WAS INSERTED INTO THE 4FR GLIDE CATHETER, AND IT WAS ADVANCED PAST THE ENTRAINED COIL. ANOTHER .014 WIRE WAS THEN ADVANCED UP TO THE DISTAL PART OF THE COIL WHICH SUCCESSFULLY WEDGED THE COIL BETWEEN THE WIRES. THEN, THE 4FR GLIDE CATHETER, COIL AND WIRES WERE RETRACTED THROUGH THE PATIENT¿S BODY UNDER FLURO AND WERE ALL SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163949 ↗
• MalfunctionAug 10, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A RIGHT PAVM EMBOLIZATION PROCEDURE, THE COIL AND MICROCATHETER COULD NOT ADVANCE WELL WHEN ATTEMPTING TO GET INTO THE VESSEL. WHILE ATTEMPTING TO REGAIN ACCESS INTO THE TARGET VESSEL, THE COIL WAS GOING TO BE RECAPTURED INTO THE DELIVERY SHEATH BY INSERTING A PUSHER WIRE, BUT THE COIL HAD A LOOSE PIECE AND PREMATURELY SEPARATED WHILE IT WAS STILL INSIDE THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. THE MICROCATHETER WAS FLUSHED, AND IT WAS USED TO FINISH THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957616 ↗