Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-111-80-16-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 05055715611558), received between Jun 29, 2017 and Jun 29, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
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.
InjuryJun 29, 2017Material Puncture/Hole; Material Puncture/Hole
EVENT: TYPE IIIB ENDOLEAK IDENTIFIED DURING RE-INTERVENTION PERFORMED FOR ENLARGED ANEURYSM / EXPLANT ORIGINAL EVAR PROCEDURE WAS PERFORMED ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED WITH A TYPE 4 ENDOLEAK REMAINING. ON (B)(6) 2017 (9 MONTHS POST PROCEDURE), FOLLOW-UP SCANS CONFIRMED AN ENLARGED ANEURYSM. A RE-INTERVENTION WAS PERFORMED TO IMPLANT A NEW VASCULAR PROSTHESIS. ON REMOVAL OF THE IMPLANT, IT WAS IDENTIFIED THAT THERE WAS A HOLE/TEAR IN THE GRAFT (TYPE 3B ENDOLEAK).
Patient problems: Aneurysm
MAUDE report 6676239 ↗
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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