GORE-TEX Vascular Graft ST0608Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW 6mmX80cm · 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 00733132612666), received between Oct 30, 2023 and Oct 30, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Microbial Contamination of Device1
Patient problems
- Hematoma1
- Insufficient Information1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2023Microbial Contamination of Device; Contamination /Decontamination Problem; Microbial Contamination of Device; Contamination /Decontamination Problem
THE FOLLOWING WAS REPORTED TO GORE FROM THE VIDOC STUDY DATABASE: ON (B)(6) 2015, THIS 79-YEAR-OLD PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR PERIPHERAL ARTERY DISEASE IN THE RIGHT LOWER EXTREMITY. THE PATIENT WAS TREATED WITH A GORE-TEX® STRETCH VASCULAR GRAFT. NO ADVERSE EVENTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS IMPLANTED AND RETAINED. ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED WITH RIGHT LOWER LIMB ISCHEMIA WHICH REQUIRED INTERVENTION. MEDICAL/SURGICAL INTERVENTION, AT THAT TIME, IS UNKNOWN (B)(4). SEVERAL WEEKS LATER, ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED WITH ¿PROSTHETIC (DISTAL FLOW) SEPSIS (WITHIN THE GORE DEVICE) WHICH REQUIRED INTERVENTION. ON (B)(6) 2016, EVACUATION OF HEMATOMA WAS PERFORMED, NOT LOCATED WITHIN THE STUDY DEVICE, BUT INTERVENTION INCLUDED IN THE FORM OF EXPLANTATION OCCURRED. THE PATIENT DIED ON (B)(6) 2017 (B)(4).
Patient problems: Hematoma; Insufficient Information; Sepsis
MAUDE report 18030370 ↗
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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