GORE-TEX Vascular Graft RRT07070080LRecalls & reported problems
W. L. Gore & Associates, Inc. · REM RG T7MM 70CMRS X 80CM · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132611034), received between Jan 14, 2019 and Jul 26, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Contamination” (2 reports).
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
- Contamination2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bacterial Infection1
- Pyogenic Infection1
- Thrombosis1
- Thrombosis/Thrombus1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2022Contamination; Contamination
IT HAS BEEN REPORTED TO GORE THAT, ON (B)(6) 2016 THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF PERIPHERAL ARTERIAL DISEASE LOCATED IN THE COMMON FEMORAL ARTERY AND WAS TREATED WITH A GORE-TEX VASCULAR GRAFT, THE PATIENT RECEIVED HEPARIN AS AN ADDITIONAL ANTIPLATELET TREATMENT. THE PROCEDURE WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016 AN UNPLANNED OPEN SURGERY REINTERVENTION WAS PERFORMED BECAUSE OF A PERIPROSTHETIC GRAFT INFECTION AND A WOUND DRAINAGE SYSTEM WAS CONSTRUCTED. THE PATENCY OF THE DEVICE WAS MAINTAINED AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2016 AN ELECTIVE OPEN REPAIR SURGICAL REINTERVENTION WAS PERFORMED BECAUSE OF AN INFECTED VASCULAR GRAFT WHICH WAS EXPLANTED. IT WAS REPORTED THAT THE PATENCY OF THE GORE-TEX VASCULAR GRAFT WAS NOT RESTORED AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2016.
Patient problems: Pyogenic Infection
MAUDE report 15102362 ↗InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE ISCHEMIA OF THE LEFT LOWER LIMB WITH A GORE-TEX® VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED DUE TO A SEVERE RADIATION-INDUCED STENOSIS OF THE VISCERAL AORTA. IT WAS STATED THAT THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2020 AS AN AXILLO-LEFT-FEMORAL BYPASS. IT WAS REPORTED THAT ON (B)(6) , 2021, AFTER ABOUT 2 MONTHS, THE PROSTHESIS WAS EXPLANTED BECAUSE AN IN-SITU RECONSTRUCTION WAS PERFORMED. THE SURGEON NOTED THAT THE AXILLO-FEMORAL BYPASS WAS THROMBOSED, AND A SEROMA WAS NOTICED.
Patient problems: Thrombosis/Thrombus
MAUDE report 11543123 ↗InjuryDec 17, 2020Contamination; Contamination
IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A CRITICAL LIMB ISCHEMIA WITH A GORE-TEX® VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. IT WAS STATED THAT THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2019 AS A BELOW-THE-KNEE FEMORO-POPLITEAL BYPASS. IT WAS REPORTED THAT THE CLINICAL HISTORY TAKES NOTES OF SEVERAL REVASCULARIZATIONS¿ SURGERIES IN THE CONTEXT OF ISCHEMIA. IT WAS STATED THAT ON (B)(6) 2019, AFTER ABOUT 1 MONTH, TWO SEGMENTS OF THE PROSTHESIS WERE EXPLANTED DUE TO INFECTION TO STAPHYLOCOCCUS MÉTI-S.
Patient problems: Bacterial Infection
MAUDE report 11027049 ↗InjuryJan 14, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO GORE THAT A GORE-TEX® VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2018, IN A (B)(6) MALE PATIENT TO TREAT AN ACUTE ISCHEMIA LOCATED AT THE RIGHT LOWER LIMB. ON (B)(6) 2018, AFTER ABOUT 8 DAYS, THE GORE-TEX® VASCULAR GRAFT WAS EXPLANTED DUE TO A THROMBOSIS LEADING TO A TRANSFEMORAL AMPUTATION.
Patient problems: Thrombosis
MAUDE report 8245010 ↗
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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