Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-81-63-20-A12-22Recalls & reported problems

Lombard Medical Limited · Aorfix 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 05055715611879), received between Jun 24, 2016 and Jun 24, 2016 — 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
Occlusion1
Renal Failure1
Vascular Dissection1

Recent adverse event reports

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

InjuryJun 24, 2016Adverse 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 PERFORMED BY PLACING A MAIN BODY FROM THE RIGHT APPROACH FOLLOWING THE IFU. THE PHYSICIAN PLACED AND DEPLOYED A MAIN BODY (HBB-31-81), SO THAT THE FISHMOUTH TROUGH WOULD BE POSITIONED APPROXIMATELY 2 MM DISTALLY FROM THE LEFT LOWER RENAL ARTERY. THEREAFTER, HE RELEASED A SUPPORT TUBE, DEPLOYED AN IPSI-LATERAL LIMB, REMOVED THE DELIVERY SYSTEM FROM THE PATIENT'S BODY, AND INFLATED A BALLOON CATHETER FOR THE TOUCH-UP. IT WAS SEEMED TO THE PHYSICIAN THAT THE FISHMOUTH TROUGH WAS POSITIONED ABOUT 5 MM DISTALLY FROM THE LEFT LOWER RA AS A RESULT. THEN, HE PLACED A CONTRA-LATERAL LIMB (HBL-56-20) AND AN IPSI-LATERAL LIMB (HDE-20-51). AN ANGIOGRAPHY REVEALED A DEFINITIVE TYPE IA ENDOLEAK. BY INFLATING THE BALLOON CATHETER ADDITIONALLY, THE TYPE IA ENDOLEAK WAS DECREASED. THEREFORE, THE PHYSICIAN OBSERVED THE INSIDE OF THE MAIN BODY WITH AN ANGIOGRAPHY. NO ENDOLEAKS WERE CONFIRMED. THUS, HE CONCLUDED THAT IT WAS NOT A TYPE IV ENDOLEAK. THEREAFTER, HE PLACED AN EXTENDER (HPE-31-38) RIGHT BELOW THE RA. THE PROCEDURE WAS FINISHED AFTER COMPLETELY RESOLVING THE ENDOLEAK. A FOLLOW UP CT PERFORMED ON (B)(6) REVEALED THAT THE LEFT LOWE
Patient problems: Aneurysm; Occlusion; Renal Failure; Vascular Dissection
MAUDE report 5747548 ↗

Device details

UDI-DI	`05055715611879`
Brand	Aorfix AAA Stent Graft Body with Aorflex Delivery System
Model	SG-HBB-31-81-63-20-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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