Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-96-80-12-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715612074), received between Dec 16, 2016 and Dec 16, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning 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 16, 2016Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  THE ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. THE FINAL ANGIOGRAPHY REVEALED A TYPE IV ENDOLEAK. THEN, THE PROCEDURE WAS FINISHED. ON (B)(6), 6 DAYS AFTER THE PROCEDURE, THE CT IMAGE REVEALED A SUSPECTED TYPE IA ENDOLEAK. THE FOLLOW UP ANGIOGRAPHY DID NOT IDENTIFY ANY PARTICULAR ENDOLEAK. ON (B)(6), A RE-INTERVENTION WAS PERFORMED AND AN EXCLUDER PROXIMAL CUFF (32 MM, GORE) WAS ADDED AS A PRECAUTIONARY MEASURE TO PREVENT A POSSIBLE TYPE 1A ENDOLEAK OCCURING IN THE FUTURE.

  Patient problems: Aneurysm

  MAUDE report 6180322 ↗