Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-27-111-80-14-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 05055715608664), received between Apr 19, 2016 and Apr 19, 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

Recent adverse event reports

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

InjuryApr 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) THE PHYSICIAN INSERTED THE MAIN BODY BY THE RIGHT APPROACHING AND DEPLOYED THE CONTRA-LATERAL SOCKET. AFTER CANNULATING THE CONTRA-LATERAL LIMB, HE DEPLOYED THE IPSI-LATERAL LIMB OVERALL AND USED A RELIANT BALLOON CATHETER TO BETTER LAND THE DEVICE AT THE EXTERNAL ILIAC ARTERY. AFTER THE INSERTION OF THE CONTRA-LATERAL LIMB, IT WAS DEPLOYED AND MOULDED AROUND THE EXTERNAL ILIAC ARTERY. THEREAFTER, ALL THE DEVICES WERE MOULDED WITH USE OF A BALLOON CATHETER. THE ANGIOGRAPHY REVEALED A TYPE IA ENDOLEAK. THEREFORE, HE ADDED AN EXCLUDER CUFF TO RESOLVE IT AND THIS TIME, THE ANGIOGRAPHY REVEALED A TYPE IV ENDOLEAK. THE PROCEDURE WAS FINISHED. HE DECIDED TO FOLLOW-UP THE PATIENT. ON (B)(6) THE PHYSICIAN CONFIRMED AN ENDOLEAK AGAIN WITH USE OF CT. IN ORDER TO IDENTIFY DETAILS, HE PERFORMED AN ANGIOGRAPHY AND DETERMINED THAT IT WAS A TYPE IB ENDOLEAK AT THE RIGHT DISTAL PORTION. ADDITIONAL INFORMATION AS OF (B)(6) 2016 - RE-INTERVENTION THE ANGIOGRAPHY REVEALED A TYPE IB ENDOLEAK, BECAUSE THE SEALING ZONE OF THE FISHMOUTH TROUGH AT THE RIGHT DISTAL SIDE WAS ONLY 5 MM OR SO. THEREFORE, THE PHYSICIAN PLACED (B)(4) AS AN ADDITIONAL DEVICE TO THE RIGHT IPSI-LATERAL LIMB. THEREAFTER,
Patient problems: Aneurysm
MAUDE report 5586362 ↗

Device details

UDI-DI	`05055715608664`
Brand	Aorfix AAA Stent Graft Body with Aorflex Delivery System
Model	SG-HBB-27-111-80-14-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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