GORE-TEX Stretch Vascular Graft-Bifurcated SB1601DRecalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH BIFUR 16-08MM X 40CM · Class 2 · Implant
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 00733132611829), received between Feb 8, 2019 and Dec 27, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient-Device Incompatibility1
Patient problems
- Aneurysm1
- Infection, Indirect1
- Occlusion1
- Rupture1
- Thrombosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE FOLLOWING WAS REPORTED TO GORE BY GEPROMED: ON (B)(6) 2016, A 51-YEAR-OLD PATIENT WITH SOME MEDICAL HISTORY, UNDERWENT A PROCEDURE WHERE A GORE-TEX® STRETCH VASCULAR GRAFT WAS USED AS A AORTO-BIFEMORAL BYPASS IN ORDER TO TREAT A PERIPHERAL ARTERY DISEASE, PARTICULARLY CLAUDICATION. ON (B)(6) 2024, AFTER APPROXIMATELY 8 YEARS AND 8 MONTHS, THE DISTAL PART OF THE STRETCH VASCULAR GRAFT WAS EXPLANTED DUE TO MATERIAL ALTERATION, PARTICULARLY ANASTOMOTIC RUPTURE.
Patient problems: Rupture
MAUDE report 21025020 ↗InjuryOct 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTO-BI-FEMORAL BYPASS IN ORDER TO TREAT A BILATERAL CRITICAL ISCHEMIA BY USING A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED BIFURCATED. IT WAS STATED THAT THE PROSTHESIS WAS IMPLANTED USING ROBOTIC SURGERY ON (B)(6) 2015 AND IMMEDIATE POST-OPERATIVE PERIOD WAS MARKED BY A THROMBOSIS AT DAY 1 DUE TO A PROBABLE HEPARIN-INDUCED THROMBOCYTHEMIA. IT WAS STATED THAT ON (B)(6) 2019, AFTER ABOUT 4 YEARS AND 3 MONTHS OF IMPLANTATION, THE PROSTHESIS WAS EXPLANTED DUE TO THROMBOSIS, AND A NEW AORTO-BIFEMORAL BYPASS WAS PERFORMED.
Patient problems: Thrombosis
MAUDE report 10620158 ↗InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE GORE-TEX® VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2019, IN ORDER TO TREAT AN ABDOMINAL AORTA ANEURYSM. LATER IN THE SAME DAY, THE PROSTHESIS WAS EXPLANTED DUE TO A THROMBOSIS OF THE PATIENT'S LEFT LEG. THE SURGEON SPECIFIES THAT THE PERIOD BETWEEN THE THROMBOSIS AND THE EXPLANTATION IS 12 HOURS.
Patient problems: Occlusion
MAUDE report 8656631 ↗InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
ON AN UNKNOWN DATE A BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED IN ORDER TO TREAT AN UNKNOWN DISEASE. ON (B)(6) 2016, A GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED IN A (B)(6) MALE PATIENT AS AN EXTENSION OF THE PREVIOUSLY IMPLANTED BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT IN ORDER TO TREAT A CRITICAL ISCHEMIA. ON (B)(6) 2018, AFTER ABOUT TWO YEARS, THE BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT AS WELL AS THE GORE® PROPATEN® VASCULAR GRAFT WAS EXPLANTED DUE TO A FALSE ANASTOMOTIC ANEURYSM AND AN INFECTION TO STAPHYLOCOCCUS AUREUS.
Patient problems: Aneurysm; Infection, Indirect
MAUDE report 8319451 ↗
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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