GORE-TEX Vascular Graft SRRT06070080LRecalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW RR 6mmX80cm 70cm Rings · 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132612413), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 death.
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
- Obstruction of Flow1
Patient problems
- Obstruction/Occlusion1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 6, 2023Microbial Contamination of Device; Obstruction of Flow; Microbial Contamination of Device; Obstruction of Flow
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR AN OCCLUSIVE PERIPHERAL ARTERIAL DISEASE WITH A GORE-TEX® STRETCH VASCULAR GRAFT THIN WALLED REMOVABLE RINGED. IT WAS STATED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2021, IN THE INFERIOR GENICULAR POPLITEAL ARTERY TO TREAT A CRITICAL LIMB ISCHEMIA. ON (B)(6) 2022, THE DEVICE WAS EXPLANTED DUE TO A SEPTIC THROMBOSIS. THE EXPLANTED VASCULAR GRAFT WAS REPLACED BY A FEMORO-TIBIAL BYPASS. REPORTEDLY, THE PATIENT WAS FRAIL AND UNDERGOING HEMODIALYTIC TREATMENT AND HAS NO RECORDED MEDICAL HISTORY OF PRE-EXISTING INFECTION. THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD SEPTICEMIA, A HEMOCULTURE WAS CONDUCTED AND STAPHYLOCOCCUS AUREUS WAS IDENTIFIED AS THE CAUSATIVE MICRO-ORGANISM. REPORTEDLY, THE STAPHYLOCOCCUS AUREUS WAS EQUALLY IDENTIFIED ON THE GORE-TEX® STRETCH VASCULAR GRAFT. IN (B)(6) 2021 A TIBIAL ANGIOPLASTY WAS PERFORMED IN ORDER TO IMPROVE THE RUN-OFF AND COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED AN ABSCESSES ADJACENT TO THE BYPASS. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN, IT IS ASSUMED THAT THIS COULD BE THE POINT OF ENTRY FOR THE INFECTION. ON (B)(6) 2022, THE PATIENT DEC
Patient problems: Obstruction/Occlusion; Sepsis
MAUDE report 16302523 ↗
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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