Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-96-80-12-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05055715607032), received between Aug 12, 2015 and Dec 16, 2016 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2016Use of Device Problem; Use of Device Problem

  ORIGINAL EVAR WAS PERFORMED (B)(6) 2016. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH NO ISSUES. WHEN THE PATIENT WAS FOLLOWED UP ON (B)(6) 2016, THE ANGIOGRAPHY REVEALED THAT AN OCCLUSION WAS PRESENT IN THE IPSILATERAL LIMB. THE PHYSICIAN DECIDED TO PERFORM A RE-INTERVENTION THAT DAY BY PROCEEDING WITH A FEM-FEM BYPASS.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 6180804 ↗
• DeathMay 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVAR WAS PERFORMED ON (B)(6) 2016. DEATH DUE TO THE DAMAGED LEFT COMMON ILIAC ARTERY BY A MANIPULATION OF THE CONTRA-LATERAL LIMB DELIVERY SYSTEM DURING THE PROCEDURE. A MAIN BODY (HBB-24-96-80-12) WAS INSERTED BY THE LEFT APPROACHING FOLLOWING THE IFU. THEN, THE MAIN BODY DEVICE WAS DEPLOYED TOWARD THE CONTRA-LATERAL GATE. AFTER RELEASING THE SUPPORT TUBE, AN IPSI-LATERAL LIMB WAS DEPLOYED. AFTER OBSERVING A BIFURCATION OF THE LEFT INTERNAL ILIAC ARTERY WITH USE OF AN ANGIOGRAPHIC CATHETER FROM THE CONTRA-LATERAL SIDE, THE PHYSICIAN INSERTED A HBL-56-16 DELIVERY SYSTEM SIMULTANEOUSLY WHEN REMOVING THE MAIN BODY DELIVERY SYSTEM. IT WAS CONFIRMED THAT AN INSERTION OF THE DELIVERY SYSTEM BECAME DIFFICULT WHEN APPROXIMATELY 10 MM OF A PROXIMAL END PORTION OF THE HBL-56-16 DEVICE ENTERED INTO A DISTAL END OF THE IPSI-LATERAL LIMB OF THE MAIN BODY. BECAUSE THE PHYSICIAN WANTED TO OVERLAP THE DEVICE AT LEAST MORE THAN 20 MM INSIDE THE IPSI-LATERAL LIMB OF THE MAIN BODY, HE PUSHED UP THE DELIVERY SYSTEM FORCEFULLY. THEREAFTER, A SHAFT OF THE DELIVERY SYSTEM WAS EXCESSIVELY KINKED IN THE BLOOD VESSEL. EVEN AFTER THIS EVENT, HE CONTINUED PUSHING THE DELIVERY SYSTEM FORCEFULLY. THEN, THE PAT

  Patient problems: Aneurysm; Blood Loss; Cardiac Arrest; Death

  MAUDE report 5646163 ↗
• InjuryFeb 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVAR PERFORMED ON (B)(6) 2015. FOLLOW UP CT ON (B)(6) 2015 REVEALED OCCLUSION OF RIGHT AND LEFT INTERNAL ILIAC ARTERIES, HOWEVER NO ACTION WAS TAKEN AT THIS TIME. ON (B)(6) 2016, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF CLAUDICATION IN THEIR LEFT LEG. ABI WAS MEASURED AT 0.56. RE-INTERVENTION WAS PERFORMED ON (B)(6) 2016 TO IMPLANT A STENT IN THE LEFT INTERNAL ILIAC ARTERY TO RESTORE FLOW. AT THE END OF THE PROCEDURE, THE PHYSICIAN COULD CONFIRM THAT THERE WAS NO PRESSURE DIFFERENCE BETWEEN THE BRACHIAL PART AND THE LEG PART DISPLAYED ON THE MONITOR AFTER THE PLACEMENT OF THE STENT. THE PHYSICIAN BELIEVED THAT THE BLOOD FLOW SHOULD BE IMPROVED AND THE CLAUDICATION OF THE LEFT LEG WILL DISAPPEAR. THE RIGHT INTERNAL ILIAC WAS NOT ADDRESSED AS THE PATIENT WAS EXPERIENCING SYMPTOMS IN THE LEFT LEG ONLY, THEREFORE THE RIGHT INTERNAL ILIAC REMAINS OCCLUDED. THE PATIENT WILL BE FOLLOWED UP AT A LATER DATE. THE PHYSICIAN STATES THAT IT WAS VERY HARD TO DETERMINE THE LANDING POSITION OF THE DISTAL FISHMOUTH. THE PATIENT DID NOT HAVE ANY HISTORY OF PAD PRIOR TO THE PROCEDURE.

  Patient problems: Aneurysm; Claudication; Occlusion

  MAUDE report 5446651 ↗
• InjuryAug 12, 2015Insufficient Device Problem Information

  (B)(4).

  Patient problems: Aneurysm

  MAUDE report 4995379 ↗