GORE-TEX Vascular Graft ST0804Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW 8mmX40cm · Class 2 · Implant
All models of GORE-TEX Vascular Graft (17)
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 00733132612734), received between Aug 20, 2023 and Aug 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Partial Blockage” (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
- No Apparent Adverse Event1
- Partial Blockage1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2023Partial Blockage; No Apparent Adverse Event; Partial Blockage; No Apparent Adverse Event
REPORTEDLY ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® STRETCH VASCULAR GRAFT TO TREAT AN OCCLUSIVE PERIPHERAL ARTERIAL DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. REPORTEDLY ON (B)(6) 2016, AN ADVERSE EVENT TERMED "STENOSIS OF THE RIGHT FEMORAL BIFURCATION" WAS DISCOVERED, THE PRIMARY RELATIONSHIP WAS RECORDED AS PROCEDURE RELATED. A REINTERVENTION (NOT FURTHER SPECIFIED) WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT A SEQUELAE.
Patient problems: Stenosis
MAUDE report 17581218 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 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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