Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-96-80-18-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715607063), received between Aug 12, 2016 and Oct 27, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2015. A SMALL TYPE 4 ENDOLEAK REMAINED AT THE END OF THE PROCEDURE. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2016 TO TREAT THE PRESENCE OF A TYPE 2 ENDOLEAK DUE TO ANEURYSM ENLARGEMENT OF 1CM. AT THIS POINT, A TYPE 3B ENDOLEAK WAS IDENTIFIED BY THE CLINICIAN FROM A NEEDLE HOLE OF THE MAIN BODY WHERE THE STENT GRAFT WASN'T FULLY EXPANDED. THE PHYSICIAN CONSIDERED ADDING AN AORTIC CUFF INTO THE IMPLANTED AORFIX, HOWEVER, AS AN OPEN REPAIR HAD ALREADY BEEN INITIATED, THE AORFIX STENT GRAFT WAS EXPLANTED AND WAS REPLACED WITH A Y-GRAFT TO RESOLVE THE TYPE 3B ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 6059975 ↗
• InjuryAug 12, 2016Use of Device Problem; Use of Device Problem

  EVAR WAS PERFORMED (B)(6) 2016. EVENT: MAIN BODY AORFIX GRAFT PROXIMAL MIGRATION (OPEN REPAIR CONVERSION). CONTRALATERAL LIMB WAS INSERTED WITH SIGNIFICANT RESISTANCE FROM EXTERNAL ILIAC. LEFT IPSILATERAL LEG WAS CONSTRAINED 3CM PAST GATE. SURGEON ADVANCED THEN RELAXED. THIS WAS REPEATED WITH SOME SUCCESS. IT WAS NOTED THE CONTRALATERAL LUNDERQUIST WIRE AT THE BACK TABLE HAD GREATLY RETRACTED. SURGEON IMAGED PROXIMAL TO SEE WIRE POSITION AND NOTED FLOPPY END OF WIRE WAS NOW IN THE NOSECONE OF DELIVERY CATHETER. THIS RESULTED IN NOSECONE BUCKLING IN NECK ANGLE AND PUSHING GRAFT PROXIMALLY ABOVE THE LEFT RENAL ARTERY. POST ANGIO RUN OF DEPLOYED MAIN BODY AND CONTRALATERAL LEG, IMAGING REVEALED MAIN BODY GRAFT HAD MIGRATED ABOVE RENAL ARTERIES LEADING PHYSICIAN TO OPT FOR OPEN CONVERSION AND RESECTION OF IMPLANTED GRAFT(S).

  Patient problems: Aneurysm; Occlusion

  MAUDE report 5871152 ↗