Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-111-63-12-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 05055715606431), received between Dec 13, 2017 and Dec 13, 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.

InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVENT: RE-INTERVENTION FOR TYPE 2 ENDOLEAK, 1B ENDOLEAK (LEFT) AND TYPE 3B ENDOLEAK (DISTAL, POSTERIOR ASPECT OF THE BIFURCATED SEGMENT). ORIGINAL EVAR: (B)(6) 2016. TYPE 2 ENDOLEAK IDENTIFIED ON POST-OP SCAN. ONE MONTH POST-EVAR: (B)(6) 2016. CTA SCAN SHOWS SAC SIZE AT 47 X 45MM. BETWEEN 6 AND 14 MONTHS POST-EVAR: (B)(6) 2016 TO (B)(6) 2017. CTA SCANS SHOW SAC SIZE TO BE SIGNIFICANTLY ENLARGED AT 57 X 54MM. RE-INTERVENTION: (B)(6) 2017. TO TREAT ORIGINAL TYPE 2 ENDOLEAK, BUT PROCEDURE COMMENCED WITH THE VIEW THAT THE PATIENT MAY ALSO HAVE A TYPE 1B ENDOLEAK AT THE DISTAL END OF THE RIGHT LIMB OF THE STENT GRAFT. DURING RE-INTERVENTION: TYPE 1B ENDOLEAK WAS CONFIRMED FROM THE LEFT LIMB OF THE STENT GRAFT, AND A TYPE 3B ENDOLEAK WAS ALSO IDENTIFIED COMING FROM THE DISTAL, POSTERIOR ASPECT OF THE BIFURCATED SEGMENT OF THE STENT GRAFT. THE STENT GRAFT WAS COMPLETELY RELINED USING A COMBINATION OF COMPETITOR DEVICES. POST-DEPLOYMENT SCAN: ALL ENDOLEAKS RESOLVED. ONE MONTH POST-OP: (B)(6) 2017. FOLLOW-UP SCAN SHOWED NO EVIDENCE OF ENDOLEAK. HOWEVER, DELAYED IMAGES SHOWED FAINT, DIFFUSE TYPE 2 LUMBAR ENDOLEAK. MANUFACTURER AWARENESS OF THE EVENT WAS VIA DEVICE TRACKING SYSTEM.
Patient problems: Aneurysm
MAUDE report 7111919 ↗

Device details

UDI-DI	`05055715606431`
Brand	Aorfix AAA Stent Graft Body with Aorflex Delivery System
Model	SG-HBB-24-111-63-12-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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