GORE-TEX Stretch Vascular Graft S0607Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT SW 6mmX70cm · Class 2 · Implant
All models of GORE-TEX Stretch Vascular Graft (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132611317), received between Apr 26, 2022 and Oct 1, 2022 — classified as 2 injuries.
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
- Microbial Contamination of Device1
Patient problems
- Bacterial Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2022Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT PRESENTED WITH A CRITICAL ISCHEMIA BECAUSE OF STENOSIS (80 %) OF THE LEFT INTERNAL CAROTID ARTERY DUE TO CHRONIC ATHEROSCLEROTIC ARTERIAL DISEASE. REPORTEDLY, THE PATIENT HAD NO HISTORY OF SYSTEMIC INFECTION OR PREEXISTING INFECTION IN THE TREATMENT AREA. ON (B)(6) 2021, A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED AS A CAROTIDO-CAROTID BYPASS FROM THE RIGHT SIDE TO THE LEFT SIDE TO TREAT THE CRITICAL ISCHEMIA. THE ANASTOMOSES WERE AT THE RIGHT CAROTID BIFURCATION AND AT THE LEFT INTERNAL CAROTID ARTERY DISTALLY OF THE LESION. ON (B)(6) 2022, THE GRAFT WAS EXPLANTED DUE TO AN INFECTION. IT REMAINS UNKNOWN WHEN THE INFECTION WAS FIRST IDENTIFIED AND WHICH BACTERIA CONTRIBUTED TO THE INFECTION. IT REMAINS ALSO UNKNOWN WHAT FURTHER TREATMENTS WERE PERFORMED TO RESOLVE THE INFECTION. REPORTEDLY, THE PHYSICIAN DID NOT PROVIDE ANY INFORMATION AS TO WHY THE GRAFT BECAME INFECTED. IT WAS REPORTED THAT THE PHYSICIAN HAS NO SUSPICION THAT THE GORE GRAFT OR THE PROCEDURE CONTRIBUTED TO THE INFECTION.
Patient problems: Bacterial Infection
MAUDE report 15525966 ↗InjuryApr 26, 2022Contamination; Contamination
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT TO CREATE AN ACCESS FOR HEMODIALYSIS WITH A GORE-TEX® STRETCH VASCULAR GRAFT ¿ STANDARD-WALLED. IT WAS STATED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT ON (B)(6) 2021, AFTER ABOUT 4 MONTHS, THE VASCULAR GRAFT WAS EXPLANTED DUE TO INFECTION WITH STAPHYLOCOCCUS AUREUS MÉTI-R. A SEGMENT OF THE GRAFT WAS SENT FOR ANALYSIS.
Patient problems: Bacterial Infection
MAUDE report 14201693 ↗
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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