Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-111-80-12-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 05055715606493), received between Jan 22, 2016 and Jan 22, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Occlusion Within 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

Device problems

Occlusion Within Device1

Patient problems

Aneurysm1
Thrombosis1

Recent adverse event reports

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

InjuryJan 22, 2016Occlusion Within Device; Occlusion Within Device
ON (B)(6) AN URGENT PROCEDURE WAS PERFORMED WITH USE OF AORFIX STENT GRAFTS FOLLOWING THE IFU. AT THAT TIME, THE PROCEDURE WAS FINISHED WITHOUT PROBLEM.RIGHT LEG: GRAFT CONSTRICTED IN SIZE AND LEFT LEG OCCLUDED DUE TO THROMBOSIS STENT GRAFTS AND ALL DEVICES WERE PLACED APPROACHING FROM THE LEFT FEMORAL ARTERY FOR ABDOMINAL EVAR.ON (B)(6) A DEALER INFORMED MEDICO'S HIRATA OF THE OCCLUSIONS PROBLEM DUE TO THROMBOSIS.REGARDING THE LEFT LEG, THE OCCLUSION DUE TO THROMBOSIS WAS CONFIRMED FROM THE BIFURCATION OF THE MAIN BODY TO THE DISTAL PART OF THE EXTERNAL ILIAC ARTERY. REGARDING THE RIGHT LEG, APPROXIMATELY HALF OF THE GRAFT FROM THE CONTRA-LATERAL LEG WAS CONSTRICTED IN SIZE.BUT THE RING STENT ITSELF WAS FULLY EXPANDED.ADDITIONAL PROCEDURE: SURGICALLY, A THROMBECTOMY WAS CONDUCTED. AFTER THE CUTDOWN, ACT VALUE WAS MEASURED. WITH A UNIT OF 11,000 INTRAVENOUS INJECTION WAS CONDUCTED AND ACT VALUE SHOWED 237. ABOUT EVERY 30 MINUTES, ADDING IT WITH A UNIT OF 1500, AND FINALLY, THE ACT VALUE SHOWED 228 AFTER APPROXIMATELY ONE HOUR. THE PROCEDURE WAS FINISHED.ANATOMY: PROXIMAL NECK ANGULATION: 131 DEGREE. OUTSIDE THE IFU.PHYSICIAN'S COMMENT: IT IS DIFFICULT TO IDENTIFY A CAUSE OF
Patient problems: Aneurysm; Thrombosis
MAUDE report 5384759 ↗

Device details

UDI-DI	`05055715606493`
Brand	Aorfix AAA Stent Graft Body with Aorflex Delivery System
Model	SG-HBB-24-111-80-12-A12-22
Company	Lombard Medical Limited
Product code	MIH · System, Endovascular Graft, Aortic Aneurysm Treatment
Class	Class 3
FDA submission	P110032
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 24, 2025

Device type (GMDN): Aortoiliac endovascular stent-graft

A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.

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All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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