Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-81-80-20-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 05055715606899), received between Dec 16, 2016 and Dec 16, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Problem” (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
- Positioning 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 16, 2016Positioning Problem; Positioning Problem
THE ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. AN AORFIX MAIN BODY WAS PLACED (LEFT SIDE) AND AN EXCLUDER CUFF (23MM X 10CM, GORE) WAS DEPLOYED AS THE CONTRALATERAL LEG (RIGHT SIDE). THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO ENDOLEAKS. CT IMAGES TAKEN ON (B)(6) 2016 REVEALED A TYPE IB ENDOLEAK WAS PRESENT AT THE LEFT COMMON ILIAC ARTERY ON THE IPSILATERAL SIDE. THE PATIENT WAS FOLLOWED UP AT THIS STAGE IN ORDER TO MONITOR THE ENDOLEAK. AFTER CONTINUOUS FOLLOW UP OF THE PATIENT, IT WAS DECIDED THAT AN ADDITIONAL PROCEDURE WAS REQUIRED. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2016 TO EMBOLIZE THE LEFT INTERNAL ILIAC ARTERY WITH COILS AND AN EXCLUDER CUFF (12MM X 12CM, GORE) WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY. THE TYPE IB ENDOLEAK WAS RESOLVED.
Patient problems: Aneurysm
MAUDE report 6180792 ↗
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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