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Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-27-96-80-18-A12-22Recalls & reported problems

Lombard Medical Limited · Aorflex AAA Stent Graft Body with Aorflex Delivery System · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715609227), received between Mar 8, 2017 and Mar 8, 2017 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Aneurysm1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES. DURING THE 3 MONTH FOLLOW-UP ((B)(6) 2017), AN ANGIOGRAPHY REVEALED A TYPE 1A ENDOLEAK. A RE-INTERVENTION WAS SCHEDULED AND PERFORMED ON (B)(6) 2017 PERFORMING A COIL EMBOLIZATION (APPROXIMATELY 50 PIECES OF COILS) TO RESOLVE THE ENDOLEAK. THE RE-INTERVENTION WAS SUCCESSFUL.

    Patient problems: Aneurysm

    MAUDE report 6386797 ↗

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

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