Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-81-80-14-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 05055715611909), received between Sep 22, 2016 and Sep 22, 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
- Atherosclerosis1
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVENT: LEFT COMMON FEMORAL ARTERY DAMAGED BY MAIN BODY DELIVERY SYSTEM. THE PROCEDURE WAS INITIATED BY INSERTING A MAIN BODY FROM THE LEFT COMMON FEMORAL ARTERY APPROACH, THEN THE PHYSICIAN PLACED A CONTRALATERAL LIMB (HBL) FROM THE RIGHT APPROACH AND DISTAL EXTENDER FROM THE LEFT APPROACH. THE PHYSICIAN EXPERIENCED DIFFICULTY IN INSERTING THE MAIN BODY DELIVERY SYSTEM BY APPROACHING FROM THE LEFT COMMON FEMORAL ARTERY. EVENTUALLY, ALL THE PLANNED DEVICES WERE PLACED SUCCESSFULLY AND NO ENDOLEAKS WERE CONFIRMED. FINAL ANGIOGRAPHY REVEALED DAMAGE TO THE LEFT COMMON FEMORAL ARTERY. A PIECE OF VASCULAR PROSTHESIS (APPROXIMATELY 3 CM IN LENGTH) WAS INSERTED TO REPAIR THE DAMAGE AND THE PROCEDURE WAS FINISHED.
Patient problems: Aneurysm; Atherosclerosis; Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 5969385 ↗
Other System, Endovascular Graft, Aortic Aneurysm Treatment devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
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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