Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-111-80-14-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715606509), received between Jun 7, 2016 and Jan 25, 2017 — classified as 2 injuries.

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 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. AFTER DEPLOYING THE CONTRALATERAL GATE, THE SUPPORT TUBE WAS RELEASED. THE CONTRALATERAL LEG WAS CANNULATED AND THE PROXIMAL PORTION WAS TOUCHED-UP. THE IPSILATERAL LIMB OF THE MAIN BODY WAS DEPLOYED. AN EXCLUDER CUFF (27 MM) WAS ADDED TO THE CONTRALATERAL SIDE AND ANOTHER EXCLUDER CUFF (12 MM) ADDED TO THE IPSILATERAL SIDE. ON COMPLETION OF THE PROCEDURE, THE FINAL ANGIOGRAPHY REVEALED A COMPLETE OCCLUSION OF THE LEFT LOWER RENAL ARTERY. THE PHYSICIAN ATTEMPTED TO LOCATE THE LEFT RENAL ARTERY WITH A GUIDEWIRE OF 0.035 MM FROM THE BRACHIAL ARTERY APPROACH BUT THIS WAS NOT POSSIBLE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE LEFT RENAL ARTERY REMAINING OCCLUDED.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 6275550 ↗
• InjuryJun 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE WAS PERFORMED ON (B)(6) 2016 AND LATER THE SAME DAY, THE CLINICIAN CALLED THE SALE REPRESENTATIVE TO CHECK THE MRI COMPATABILITY OF THE GRAFT. THIS WAS BECAUSE THE PATIENT WAS DEVELOPING LOWER-LIMB PARALYSIS AND THERE WAS A SUSPICION OF LUMBAR ARTERY ISCHEMIA THAT NEEDED TO BE INVESTIGATED. SUBSEQUENT TO THE FIRST MRI, A SECOND ONE PERFORMED SHORTLY AFTER PROVIDED SOME EVIDENCE OF COMPROMISED FLOW. ON THE (B)(6) 2016, THE CLINICIAN CONFIRMED THAT THE PATIENT HAS SUFFERED PERMANENT LOWER BODY PARALYSIS AS WELL AS LOSS OF BLADDER AND BOWEL CONTROL. THE CLINICIAN ALSO INDICATED THE RARITY OF THE COMPLICATION AND INDICATED THERE WAS NO INFORMATION TO SUGGEST THE EVENT WAS DEVICE-RELATED. THE CLINICIAN IS CERTAIN THAT THE EVENT IS PROCEDURE-RELATED AND IS A MOST UNFORTUNATE CONSEQUENCE OF AN ALREADY COMPROMISED SPINAL CIRCULATION.

  Patient problems: Aneurysm; Incontinence; Ischemia; Paralysis

  MAUDE report 5702633 ↗