AZUR 45-880010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842429118047), received between Mar 28, 2025 and Sep 25, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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.

• MalfunctionSep 25, 2026Premature Separation

  As reported, the Hydropack detached inside the microcatheter. The microcatheter was changed, and a competitor device was used to complete the procedure. Additional information received indicated that each device was removed along with the microcatheter. The procedure was successful and there was no patient impact reported. The Hydropacks are not available because the account discarded them.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900100 ↗
• MalfunctionSep 25, 2026Premature Separation

  As reported, the Hydropack detached inside the microcatheter. Additional information received indicated that each device was removed along with the microcatheter. The case was completed by changing the microcatheter and using competitor coils. The procedure was successful. There was no patient impact reported. The Hydropacks are not available because the account discarded them.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899912 ↗
• InjuryMay 31, 2026Unraveled Material

  IT WAS REPORTED THAT DURING A LUMBAR BLEED EMBOLIZATION PROCEDURE, COILS WERE SUCCESSFULLY DEPLOYED TO CREATE AN ADEQUATE PACK. THE PARENT CATHETER WAS JAMMED IN THE PACK AND WHEN REMOVED, IT PULLED A PORTION OF THE COIL INTO THE AORTA. THE PHYSICIAN THEN USED A SNARE TO RETRIEVE THE COIL SUCCESSFULLY. THE COIL WAS OBSERVED TO BE UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344985 ↗
• MalfunctionMay 4, 2026Premature Activation; Premature Separation

  IT WAS REPORTED THAT GDA EMBOLIZATION. A FEMORAL ACCESS VIA 6F SHEATH, 5F BASE CATHETER USED AND A 2.4FX110CM PROGREAT AND 016 GWGT TO ACCESS CELIAC TO GDA. SOME KICKBACK WAS OBSERVED WITH CATHETER MAINTAINING SUPPORT INTO THE CELIAC TRUNK THROUGHOUT THE CASE. DEPLOYED TWO 018CX COILS FIRST TO CREATE A BACK STOP AND HAD NO ISSUES. DEPLOYED A 10CM HYDROPACK WITH NO ISSUE. WENT TO DEPLOY THE SECOND 10CM HYDROPACK AND THE BLACK STOPPER GOT STUCK IN THE HOOP AND CAUSED THE COIL INTRODUCER SHEATH TO STAY IN THE HOOP. WHEN THE TECH WAS FINALLY ABLE TO GET THE COIL OUT OF THE HOOP, THE TECH FELT SOME RESISTANCE. THE PHYSICIAN AND I BOTH EXAMINED THE COIL ON THE BACK TABLE AND DECIDED NOT TO USE IN THE PATIENT BECAUSE WE WERE CONCERNED ABOUT POTENTIAL STRETCHING TO THE CONNECTION POLYMER AND THE COIL BODY ITSELF. A SECOND 10CM HYDROPACK WAS PULLED. NO ISSUES REMOVING FROM THE HOOP. AS THE PHYSICIAN WAS ADVANCING THIS HYDROPACK THROUGH THE PROGREAT IT SELF-DETACHED. THE PHYSICIAN WAS ABLE TO CONTAIN IT WITHIN THE PROGREAT, REMOVE THE MICROCATHETER ENTIRELY FROM THE BODY AND SAFELY REMOVE THE COIL FROM THE MICROCATHETER. UNFORTUNATELY, THE COIL WAS HANGING OUT OF THE PROGREAT SLIGHTLY AND EN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075363 ↗
• InjuryMar 31, 2026Migration

  AS REPORTED: DEEP VENOUS ARTERIALIZATION (DVA) PROCEDURE OF RIGHT FOOT VIA RIGHT FEMORAL ARTERY AND PEDAL ACCESS, SUCCESSFUL DVA PERFORMED. ARTERIAL FLOW IN PEDAL VEIN CONFIRMED BY PHYSICIAN. IT WAS DECIDED BY PHYSICIAN TO EMBOLIZE A BRANCH COMING OFF MAIN VESSEL NEAR THE ANKLE OF THE TARGET FOOT. CATHETER, 135CM 0.018, ADVANCED TO TARGET AREA. DETACHABLE COIL ADVANCED AND SUCCESSFULLY DEPLOYED AT TARGET, WHICH HAD NEWLY ACQUIRED ARTERIAL FLOW. HYDROPACK ADVANCED TO TARGET AREA. DETACHER CONNECTED TO HYDROPACK, NO GREEN LIGHT OBSERVED ON DETACHMENT DEVICE. DETACHMENT DEVICE WAS DISCONNECTED AND REATTACHED 3 ADDITIONAL TIMES WITH THE SAME RESULT. PHYSICIAN DECIDED TO REMOVE THE HYDROPACK. PHYSICIAN DISCOVERED THE HYDROPACK WAS DETACHED FROM THE DELIVERY SYSTEM WHEN REMOVAL OF THE HYDROPACK WAS ATTEMPTED. HYDROPACK WAS DEPLOYED NEAR TARGET AREA. HYDROPACK IN QUESTION WAS OBSERVED MOVING INTO NON-TARGET VESSEL BY THE PHYSICIAN. PHYSICIAN DECIDED TO SECURE THE HYDROPACK AGAINST THE VESSEL WALL USING A COMPETITOR'S COVERED STENT OF UNKNOWN SIZE. POST PROCEDURE IMAGES OBTAIN BY THE PHYSICIAN. PATIENT STABLE POST PROCEDURE AS PER PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749850 ↗
• MalfunctionFeb 18, 2026Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS BEING USED IN A CASE TO TREAT A GI BLEED. WHEN THE COIL WAS BEING PUT INTO THE DESIRED LOCATION THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. REPORTEDLY, THE PHYSICIAN WAS ABLE TO GET THE COIL PLACED PROPERLY AND THE CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384346 ↗
• InjurySep 9, 2025Unintended Movement; Difficult or Delayed Separation; Unintended Movement; Difficult or Delayed Separation

  AS REPORTED: DURING AN EMBOLIZATION OF AN SMA TO IMA TYPE 2 ENDOLEAK, A 10CM HYDROPACK COIL WAS DETACHED BEHIND A 5MM AZUR VASCULAR PLUG AND ANOTHER 5CM AZUR HYDROPACK. WHILE ATTEMPTING TO DETACH THE 10CM HYDROPACK COIL, WHEN WE WENT TO RETRACT THE COIL, MUCH OF THE COIL PACK CAME BACKWARDS. IT LOOKED LIKE A PORTION OF THE COIL WAS STILL ATTACHED BY A WIRE FILAMENT AS IF IT WAS PARTIALLY DETACHED. THE COIL WAS EVENTUALLY FULLY DETACHED USING THE CONTROLLER BUT RESULTED IN OCCLUDING A VESSEL THAT THE PHYSICIAN DID NOT WANT TO BE OCCLUDED. THE PROCEDURE WAS COMPLETED USING THE AZUR VASCULAR PLUG AND 3 SUBSEQUENT HYDROPACK COILS; PROPER STASIS WAS ACHIEVED WITH THE COILS. DEVICE REMAINS IMPLANTED. NO OTHER IMPACT, INJURY OR INTERVENTION NOTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23000413 ↗
• MalfunctionMay 30, 2025Premature Separation; Premature Separation

  AS REPORTED: RT RENAL AV FISTULA EMBOLIZATION VIA RFA. 65CM PRIMARY CATHETER ADVANCED TO TARGET AREA FOLLOWED BY 2.4F X 130CM PROGREAT. 18 AZUR OF UNKNOWN SIZE SUCCESSFULLY DEPLOYED. COIL IN QUESTION INSERTED AND ADVANCED OUT OF PROGREAT. PHYSICIAN DID NOT LIKE THE WAY COIL WAS SETTING BEHIND CX. COIL IN QUESTION BROUGHT BACK INTO PROGREAT. SOME RESISTANCE EXPERIENCED UPON RECAPTURING REMOVING HYDROPACK. COIL IN QUESTION SEPARATED FROM DELIVERY DEVICE WITHIN 2.4 PROGREAT. PROGREAT WITH DETACHED HYDROPACK REMOVED. NEW 2.4 PROGREAT CATHETER INSERTED AND ADVANCED TO TARGET AREA. MULTIPLE HYDROPACK COILS SUCCESSFULLY DEPLOYED AT TARGET AREA. SUCCESSFUL EMBOLIZATION OF RENAL ANEURISMAL AV FISTULA PERFORMED. PATIENT STABLE AS PER STAFF. COIL IN QUESTION DISPOSED OF BY STAFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118792 ↗
• InjuryMar 28, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING VISCERAL EMBOLISATION, THE COIL DETACHED ITSELF PREMATURELY WITHOUT THE USE OF A CONTROLLER. THE COIL HAD TO BE SNARED SINCE IT DETACHED AT THE WRONG PLACE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720257 ↗