GORE-TEX Vascular Graft ST0701Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW 7mmX10cm · 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
- 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 00733132612680), received between Dec 2, 2019 and Aug 30, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Hematoma1
- Hernia1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT HAS BEEN REPORTED TO GORE THAT, ON (B)(6) 2016, THIS PATIENT UNDERWENT A SURGICAL REPAIR OF PERIPHERAL ARTERIAL DISEASE LOCATED IN THE COMMON FEMORAL ARTERY AND WAS TREATED WITH A GORE-TEX® STRETCH VASCULAR GRAFT, THE PATIENT RECEIVED HEPARIN AS AN ADDITIONAL ANTIPLATELET TREATMENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE, IT WAS ALSO RECORDED THAT THE PROCEDURE WAS UNEVENTFUL, THE DEVICE WAS IMPLANTED AND RETAINED, AND THAT THE PATIENT WAS DISCHARGED ON (B)(6), 2016. ON (B)(6) 2016, AN ADVERSE EVENT TERMED "HEMATOMA EVACUATION OF THE RIGHT SCARPA" WAS REPORTED. IT WAS RECORDED IN THE REGISTRY THAT THIS ADVERSE EVENT IS PROCEDURE-RELATED, REQUIRED AN INTERVENTION/TREATMENT AND RESOLVED WITHOUT SEQUALAE.
Patient problems: Hematoma
MAUDE report 17649065 ↗InjuryDec 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH ROLLED OFF TO THE RIGHT SIDE REQUIRING REVISION SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; No Code Available; Unspecified Infection
MAUDE report 9398912 ↗
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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