GORE-TEX Vascular Graft ST0507Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW 5mmX70cm · 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 00733132612581), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fistula1
- Ischemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® VASCULAR GRAFT. IT WAS RECORDED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2022, IN ORDER TO CREATE AN ACCESS FOR HEMODIALYSIS. REPORTEDLY, ON (B)(6) 2022, AFTER ABOUT 2 WEEKS, THE VASCULAR GRAFT WAS EXPLANTED DUE TO AN FISTULA STEAL SYNDROME. ACCORDING TO THE MOST RECENT INFORMATION, IT WAS REPORTED THAT ANOTHER DEVICE WAS IMPLANTED AND THAT THERE WAS NO ALLEGATION AGAINST THE GORE-TEX® VASCULAR GRAFT IN TERMS OF CONTRIBUTING TO THE FISTULA STEAL SYNDROME. REPORTEDLY, THE PATIENT IS DOING WELL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Ischemia
MAUDE report 15231389 ↗
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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