GORE-TEX Vascular Graft ST0807Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH THIN WALL 8MM X 70CM · 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 00733132612758), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
Patient problems
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2022Contamination; Contamination
IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED ON (B)(6) 2021 WITH MASSIVE BLEEDING DUE TO ARTERIAL PERFORATION WITH A LARGE SHEATH DURING ENDOVASCULAR TREATMENT FOR A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). IN AN EMERGENCY SURGICAL TREATMENT AN ILIO-FEMORAL BYPASS WAS PERFORMED WITH A GORE-TEX® STRETCH VASCULAR GRAFT THIN-WALLED. REPORTEDLY, ON (B)(6) 2021, AFTER ABOUT ONE MONTH, THE PROSTHESIS WAS EXPLANTED DUE TO AN BACTERIAL WOUND INFECTION WITH PROTEUS MIRABILIS, MORGANELLA MORGANIIET AND ENTEROCOCCUS FAECALIS BACTERIES. IT WAS STATED THAT THE EXPLANTED DEVICE WAS REPLACED WITH AN ALLOGRAFT.
Patient problems: Post Operative Wound Infection
MAUDE report 13533962 ↗
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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