Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-111-80-20-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715611572), received between Dec 9, 2015 and Dec 9, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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 9, 2015Malposition of Device

  THE ORIGINAL PROCEDURE WAS PERFORMED ON THE (B)(6) 2015. THE PATIENT UNDERWENT ABDOMINAL EVAR BY THE LEFT APPROACH. THE PHYSICIAN PLACED THE FISHMOUTH TROUGH JUST BELOW THE RIGHT RENAL ARTERY. BECAUSE HE WAS AFRAID THAT THE STENT GRAFT MIGHT COVER THE LOWER LEFT RENAL ARTERY, HE REMOVED THE DELIVERY SYSTEM AND TOUCHED-UP BY BALLOONING UNDER THE CONDITION OF INSERTING AN ANGIOGRAPHIC CATHETER FROM THE RIGHT BRACHIAL ARTERY. BOTH THE RIGHT AND LEFT RENAL ARTERIES IMAGES WERE REVEALED AT THE FINAL ANGIOGRAPHY. THE PROCEDURE WAS FINISHED. ON THE (B)(6) 2015, THE POST-OPERATIVE CT REVEALED THAT THE STENT GRAFT WAS COVERING THE RIGHT RENAL ARTERY AND AS A RESULT, IT WAS OCCLUDED. PATIENT'S CONDITION: RENAL FUNCTION DETERIORATION, CREATININE LEVEL 1.3 MG/DL. THE PATIENT WILL BE FOLLOWED UP AS PER STANDARD PROCEDURES.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 5278420 ↗