Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-96-80-14-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715607049), received between Oct 14, 2015 and Oct 14, 2015 — classified as 1 death, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathOct 14, 2015No Apparent Adverse Event

  THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2015 WHEN THE MAIN BODY AND LIMB WERE IMPLANTED AS PER IFU. THE INITIAL CHECK REVEALED WHAT APPEARED TO BE A TYPE 1A ENDOLEAK. RE-BALLOONING THE PROXIMAL END OF THE MAIN BODY APPEARED TO REDUCE THE LEAK. THE PHYSICIAN DECIDED TO IMPLANT A GORE EXCLUDER AORTIC CUFF TO PROVIDE WHAT HE CONSIDERED ADDITIONAL RADIAL FORCE, BUT THE TYPE 1A ENDOLEAK APPEARED TO BE PRESENT. A PALMAZ STENT WAS IMPLANTED. THE PROXIMAL SECTION OF THE PALMAZ EXTENDED ACROSS THE ORIGINS OF BOTH RENAL ARTERIES, ABOVE THE AORFIX DEVICE. FURTHER SCANS SHOWED WHAT THE PHYSICIAN CONSIDERED TO BE EITHER A TYPE 3 OR TYPE 4 ENDOLEAK. THE DECISION WAS MADE BY THE PHYSICIAN TO REVIEW THE 30-DAY FOLLOW UP CT TO ASSESS THE SITUATION FURTHER. BOTH RENAL ARTERIES APPEARED PATENT ON THE FINAL ANGIOGRAPHIC RUNS. ADDITIONAL INFORMATION RECEIVED 23 SEP 15 DESCRIBES THAT THE PATIENT DIED FROM MI (MYOCARDIAL INFARCTION) 2 WEEKS POST OP. THE PHYSICIAN SAID PRIOR TO THE CASE THAT THIS PATIENT HAD TO BE CLEARED BY HIS CARDIOLOGIST PRIOR TO THE PROCEDURE. THERE WAS APPARENT HISTORY OF HEART DISEASE.

  Patient problems: Aneurysm; Myocardial Infarction

  MAUDE report 5146752 ↗
• InjuryOct 14, 2015Malposition of Device

  DURING THE ORIGINAL PROCEDURE PERFORMED ON (B)(6) 2015, AORFIX MAIN BODY SG-HBB-24-96-80-14 WAS POSITIONED TOO HIGH PROXIMALLY AND SEEMED TO PARTIALLY COVER THE LEFT RENAL ARTERY. AORTOGRAM SHOWED THE LEFT RENAL HAS FLOW AND THE PROCEDURE WAS COMPLETED. AN ATTEMPT WAS MADE ON (B)(6) 15 TO ACCESS THE LEFT RENAL AND PLACE A STENT BUT THIS WAS UNSUCCESSFUL. PATIENT IS DOING FINE, HOWEVER PATIENT CREATININE IS RISING. FURTHER INFORMATION WAS RECEIVED ON THE (B)(6) 2015, DESCRIBING THAT THE PATIENT UNDERWENT A SECOND RE-INTERVENTION AND A RENAL ARTERY BYPASS WAS SUCCESSFULLY PERFORMED. THE PATIENT IS RECOVERING WELL.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 5146738 ↗