GORE-TEX Vascular Graft ST0601Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW 6mmX10cm · 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 00733132612598), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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
- Microbial Contamination of Device1
Patient problems
- Bacterial Infection1
- 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.
InjuryJul 21, 2023Microbial Contamination of Device; Microbial Contamination of Device
ON (B)(6) 2015, A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED FOR DIALYSIS ACCESS IN A STUDY PATIENT'S LEFT ARM. THE VASCULAR GRAFT WAS IMPLANTED FROM BRACHIAL ARTERY TO CEPHALIC VEIN WITH NO ISSUES. PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015. AS REPORTED, THE MOST RECENT ACCESS PRIOR TO IMPLANT WAS A FISTULA IN THE PATIENT'S PROXIMAL LEFT ARM. THIS ACCESS WAS ABANDONED DUE TO STENOSIS. ON (B)(6) 2015, SURGICAL SITE INFECTION WAS OBSERVED. PER STUDY INFORMATION, THIS WAS A PROCEDURE-RELATED INFECTION THAT REQUIRED MEDICAL OR SURGICAL INTERVENTION. ON (B)(6) 2016, THE VASCULAR GRAFT WAS EXPLANTED DUE TO INFECTION THAT SPREAD TO THE VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: Bacterial Infection; Post Operative Wound Infection
MAUDE report 17373774 ↗
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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