Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-96-80-20-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 05055715607070), received between Sep 23, 2016 and Sep 23, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
Patient problems
- Aneurysm1
- Occlusion1
- Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ORIGINAL EVAR WAS PERFORMED (B)(6) 2016. A MAIN BODY WAS INSERTED BY THE RIGHT APPROACH IN ACCORDANCE TO THE IFU. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH NO ISSUES. WHEN THE PATIENT WAS FOLLOWED UP, THE ABI (ANKLE BRACHIAL INDEX) VALUE BECAME WORSE. THE PHYSICIAN CONFIRMED THAT THROMBUS WAS PRESENT INSIDE THE LEFT CONTRALATERAL LIMB. THE ANGIOGRAPHY REVEALED THE INTERNAL ILIAC ARTERY HOWEVER THE PROXIMAL PORTION WAS OCCLUDED. THE PHYSICIAN ASPIRATED THE THROMBUS INSIDE THE CONTRALATERAL SOCKET WITH A CATHETER SHAPED VS THEN INFLATED THE BALLOON CATHETER. THE INTERNAL ILIAC ARTERY REMAINED OCCLUDED AND THE PHYSICIAN TRIED TO RESOLVE BY ATTEMPTING TO PUSH UP THE DISTAL CONTRALATERAL LIMB WITH A CODA BALLOON. IN ADDITION IT WAS CONFIRMED THAT THE EXTERNAL ILIAC ARTERY WAS STENOSED, THIS WAS RESOLVED AND THE ABI VALUE WAS RECOVERED. THE PROCEDURE WAS COMPLETED BY PLACING AN EXPRESS (VASCULAR) LD10-37 IN THE DISTAL PORTION OF THE CONTRALATERAL LIMB.
Patient problems: Aneurysm; Occlusion; Thrombus
MAUDE report 5972522 ↗
Other System, Endovascular Graft, Aortic Aneurysm Treatment devices
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- 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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