Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-34-111-80-12-A10-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715637299), received between Dec 8, 2015 and Dec 8, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2015Use of Device Problem

  RECEIPT RECORD 1: A TYPE 1A ENDOLOEAK PERSISTED AFTER DEPLOYING A MAIN BODY STENT GRAFT AND PROXIMAL CUFF. RATHER THAN USE FURTHER ENDOVASCULAR TECHNIQUES TO RESOLVE THE LEAK, THE PHYSICIAN DECIDED TO EXPLANT THE DEVICES AND SURGICALLY REPAIR THE AAA. RECEIPT RECORD 2: A 34MM DIAMETER 56MM LONG PROXIMAL CUFF WAS IMPLANTED IN AN ATTEMPT TO RESOLVE A TYPE 1A ENDOLEAK. DUE TO THE POSITION OF THE PRIMARY STENT GRAFT ((B)(4)) AND THE NECK ANATOMY, THE CUFF WAS ROTATED WITH ITS PROXIMAL FRONT AND BACK JAWS COVERING THE FISHMOUTH TROUGHS OF THE MAIN BODY. ON DEPLOYMENT, IT WAS OBSERVED THAT THE CUFF DISTAL PEAKS HAD DEPLOYED IN THE TOP OF THE MAIN BODY IPSILATERAL LIMB. ON SUBSEQUENT ANGIOGRAPHIC CHECKS, DELAYED CONTRAST FLOW WAS OBSERVED TO FLOW DOWN THE CONTRALATERAL LEG. IMPLANTS USED IN THIS CASE: (B)(4).

  Patient problems: Aneurysm

  MAUDE report 5273728 ↗