Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-27-96-80-16-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715609210), received between Aug 4, 2015 and Jan 21, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Advance” (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.

• InjuryJan 21, 2016Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY SUPPOSED TO UNDERGO ABDOMINAL EVAR BY THE RIGHT FEMORAL ARTERY APPROACH. NO ABNORMALITIES IDENTIFIED AT PRE-OPERATIVE CT. THE PHYSICIAN ATTEMPTED TO INSERT A MAIN BODY DEVICE ALIGNING WITH THE EGOIST GUIDEWIRE (ASAHI-INTECC). HOWEVER, THE MAIN BODY WAS ENTRAPPED WITH SOMETHING AND WOULD NOT ADVANCE. THEN, HE INSERTED A DRY SEAL (GORE, 18 FR) AS A TRIAL DEVICE AND IT ADVANCED SMOOTHLY WITHOUT PROBLEM. THEREFORE, NOW HE RE-ATTEMPTED TO INSERT THE MAIN BODY AGAIN, BUT IT WOULD NOT ADVANCE. FINALLY, HE ATTEMPTED TO INSERT A DRY SEAL (GORE, 22 FR), BUT THE MAIN BODY WOULD NOT ADVANCE THIS TIME, TOO. ADDITIONAL ACTION TAKEN BY THE PHYSICIAN: HE OBSERVED DAMAGES IN TUNICA INTIMA OF BLOOD VESSELS. THEN, HE ATTEMPTED TO FIX THEM. FOLLOWING IT, HE SWITCHED TO THE EXTERNAL ILIAC ARTERY APPROACH, PALPATED IT AND FOUND THAT IT WAS WITH ENTIRE CIRCUMFERENCE OF CALCIFICATION. HE GAVE UP PERFORMING EVAR AND CHANGED TO VASCULAR PROSTHESIS IMPLANTATION. PROCTOR'S COMMENT: PRE-OPERATIVE CT REVEALED NO ABNORMALITIES. I CANNOT ASSUME THE CAUSE OF THIS TROUBLE. ONE OF POSSIBLE CAUSES MIGHT BE STIFF BLOOD VESSELS OF THE PATIENT (B)(6) 2015 - SINCE THE EVAR SWITCHED TO THE VASCUL

  Patient problems: Aneurysm; Calcium Deposits/Calcification

  MAUDE report 5382391 ↗
• InjuryAug 4, 2015Obstruction of Flow

  THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2015 WHICH WAS COMPLETED WITHOUT ENDOLEAK. THE FOLLOW-UP CT, PERFORMED ONE WEEK AFTER THE ORIGINAL PROCEDURE, SHOWED THAT THE STENT GRAFT PARTIALLY COVERED THE RIGHT RENAL ARTERY, ALTHOUGH IT IS POSSIBLE TO SEE THERE IS CONTRAST AGENT FLOW. ON (B)(6) 2015, THE COMPANY BECAME AWARE THAT A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2015 (10 DAYS AFTER THE INITIAL PROCEDURE) TO IMPLANT A RENAL STENT WHICH SUCCESSFULLY RESOLVED THE PARTIALLY OCCLUDED RENAL ARTERY. DHR REVIEW: A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE HAS NOT MET THE FINAL RELEASE CRITERIA. CASE REVIEW (INCLUDING SIZING SHEET AND SCAN REVIEW WHERE REQUIRED): ORIGINAL EVAR WAS PERFORMED (B)(6) 2015. ON COMPLETION OF THE SURGERY, THE PHYSICIAN WAS AWARE THAT A RENAL STENT MAY BE REQUIRED AT A LATER DATE. THE RIGHT RENAL ARTERY WAS SUSPECTED TO BE PARTIALLY BLOCKED. THE FOLLOW UP CT SCAN PERFORMED ONE WEEK AFTER THE ORIGINAL PROCEDURE CONFIRMED THAT THE STENT GRAFT WAS PARTIALLY COV

  Patient problems: Aneurysm

  MAUDE report 4975922 ↗