Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-111-80-18-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715606523), received between Jan 11, 2016 and Jan 11, 2016 — 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.

• InjuryJan 11, 2016Malposition of Device; Malposition of Device

  THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2015. STENT GRAFTS WERE PLACED FROM THE RIGHT APPROACH FOR THE EVAR. IPSILATERAL RIM WAS FULLY EXPANDED. BUT CONTRALATERAL LEG DID NOT EXPAND ENOUGH BECAUSE THE DISTAL END OF THE LEG WAS PLACED DOWNWARD NARROW PORTION THAN PLANNING POSITION. THE PHYSICIAN PERFORMED THE TOUCH-UP FROM THE JUNCTION PART TO THE DISTAL END OF THE RIM BY RELIANT BALLOON CATHETER. FINAL ANGIOGRAPHY WAS REVEALED THE TYPE 4 ENDOLEAK. THE PATIENT WILL BE FOLLOWED-UP. ON (B)(6) 2015 (4 DAYS LATER FROM THE OPERATION) CT WAS REVEALED THE LEFT RIM OCCLUSION. THE PHYSICIAN PERFORMED THE F-F BYPASS FOR THE PATIENT BY USING A PROPATEN PROSTHESIS (8MM).

  Patient problems: Aneurysm; Obstruction/Occlusion

  MAUDE report 5356590 ↗