GORE-TEX Stretch Vascular Graft S46045Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT SW 4-6mmX45cm Tapered · 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 00733132611492), received between Aug 30, 2023 and Sep 4, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage1
- Partial Blockage1
- Patient-Device Incompatibility1
Patient problems
- Obstruction/Occlusion1
- Reduced Blood Flow1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR A HUMERO AXILLARY DIALYSIS ACCESS WITH A GORE-TEX® STRETCH VASCULAR GRAFT. THE DEVICE WAS IMPLANTED AND RETAINED AND THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME 1 WEEK LATER. THE FIRST ORDER TO DIALYZE THROUGH THE GRAFT WAS ON (B)(6) 2016 AND WAS SUCCESSFUL. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A VASCULAR STEAL SYNDROME ON THE HUMERO-AXILLARY PROSTHETIC LINE. PROFESSOR RINCKENBACH STATED THAT THERE IS NO ALLEGATION AGAINST THE GORE-TEX STRETCH VASCULAR GRAFT AND THAT THE GRAFT DID NOT CONTRIBUTE TO THE STEAL SYNDROME. THERE WAS A REINTERVENTION ON (B)(6) 2016, NAMELY BANDING OF THE ARTERIO-VENOUS ANASTOMOSIS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2016 AND AN ULTRASOUND PERFORMED ON (B)(6) 2016 SHOWED THAT EVERYTHING WAS OK.
Patient problems: Reduced Blood Flow
MAUDE report 17675909 ↗InjuryAug 30, 2023Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS WITH A GORE-TEX® VASCULAR GRAFT, THE ACCESS CONFIGURATION WAS RECORDED AS HUMERO-AXILLARY CONFIGURATION. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED AND THE DEVICE WAS IMPLANTED; RETAINED SUCCESSFULLY AND NO ADVERSE EVENT WAS REPORTED DURING THE PROCEDURE. ON (B)(6) 2016, AN ADVERSE EVENT TERMED "THROMBOSIS OF THE LEFT HUMERO-AXILLARY PROSTHETIC LINE (GORE GRAFT THROMBOSED))" WAS DISCOVERED AND THE PRIMARY RELATIONSHIP WAS RECORDED AS DISEASE RELATED. NO REINTERVENTION WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT A SEQUELEA.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 17649140 ↗
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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