Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System SG-HBL-106-12-A13-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715612319), received between Jun 25, 2015 and Jun 25, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryJun 25, 2015Patient-Device Incompatibility

  THE ORIGINAL PROCEDURE WAS PERFORMED ON THE (B)(6) 2015. ON THE (B)(6) 2015, THE PHYSICIAN CONTACTED THE COMPANY INFORMING THE PATIENT PRESENTED WITH SUDDEN ONSET OF CLAUDICATION DUE TO OCCLUSION OF THE HIS LEFT ILIAC. CASE REVIEW: REVIEW OF THE PRE-OPERATIVE CT SHOWED THAT BOTH LEFT AND RIGHT ILIAC VESSELS WERE HIGHLY TORTUOUS. THE POST OPERATIVE IMAGE SHOWS THE STENT GRAFT DEPLOYED THROUGH THE LEFT COMMON ILIAC ANEURYSM AND WITH TWO EXTENSION PIECES (A 12MM DIAMETER LEG AND A 18MM DIAMETER DISTAL EXTENDER). A SHARP BEND, WHICH IS APPROXIMATELY 13MM X 5MM CAN BE SEEN ON THE PROXIMAL SIDE OF THE ILIAC ANEURYSM. A 51 X 18MM DISTAL EXTENDER HAS BEEN PLACED AT THE MOST DISTAL PART OF THE LIMB AND THE PROXIMAL END HAS A PRONOUNCED, NARROW FISHMOUTH WHERE IT HAS BEEN CONSTRAINED BY THE 12MM LIMB IN WHICH IT HAS BEEN PLACED. AN ALTERNATIVE TO USING AN OVERSIZED DISTAL EXTENDER IN THIS LOCATION WOULD HAVE BEEN TO HAVE USED A SHORT FLARED LIMB, SUCH AS A 56 X 18MM, SINCE IT HAS A 12MM DIAMETER PROXIMAL CONNECTION AND AN 18MM FINAL DIAMETER. THIS WOULD HAVE AVOIDED THE RISK OF THIS OCCLUSION. THE LOMBARD PROCTOR MET WITH THE CLINICIAN ON THE (B)(6) 2015, WHO TOLD THE PROCTOR THAT THE PATIEN

  Patient problems: Aneurysm; Claudication

  MAUDE report 4873967 ↗