GORE-TEX Stretch Vascular Graft SAX01DRecalls & reported problems
W. L. Gore & Associates, Inc. · SRR 8MM X 70CM/8MM X 40CM · 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
- 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 00733132611768), received between Nov 3, 2020 and Jul 12, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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.
Reports received per month
Most reported problems
Device problems
- Microbial Contamination of Device2
- Complete Blockage1
- Contamination1
- Device Stenosis1
Patient problems
- Bacterial Infection1
- Fungal Infection1
- Stenosis1
- Thrombosis/Thrombus1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2024Microbial Contamination of Device; Device Stenosis; Microbial Contamination of Device; Device Stenosis
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR AN ACUTE ISCHEMIA OF THE LOWER LIMBS WITH A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED AXILLOBIFEMORAL REMOVABLE RINGED. THE GRAFT WAS IMPLANTED ON (B)(6) 2023, AS AN AXILLO-BI-FEMORAL BYPASS. IT WAS STATED THAT ON (B)(6) 2024, THE PATIENT PRESENTED TO EMERGENCY WITH A SIGNIFICANT BIOLOGICAL INFLAMMATORY SYNDROME AND THE BYPASS WAS THROMBOSED. A BYPASS THROMBECTOMY WAS PERFORMED ON (B)(6) 2024. SAMPLES WERE TAKEN AND FOUND TO CONTAIN A BACTERIODES FRAGILIS INFECTION, WHICH JUSTIFIED ANTI-BIOTHERAPY WITH CLINDAMYCIN. ON (B)(6) 2024, AFTER ABOUT 8 MONTHS, THE GRAFT WAS EXPLANTED FOR INFECTION AND A NEW REVASCULARISATION PROCEDURE. THE SURGEON NOTICED THAT THE DEVICE WAS THROMBOSED. A NEW RIGHT-SIDED AXILLO-FEMORAL BYPASS ASSOCIATED WITH A LEFT SUBARTICULAR FEMORO-POPLITEAL BYPASS WAS CREATED. THE PATIENT WENT INTO POSTOPERATIVE SHOCK WITH NEW THROMBOSIS OF THE BYPASS GRAFT, WITH NO POSSIBILITY OF SURGICAL INTERVENTION. COMFORT CARE WAS INITIATED, AND THE PATIENT DIED ON (B)(6) 2024.
Patient problems: Bacterial Infection; Thrombosis/Thrombus
MAUDE report 19727962 ↗InjuryMar 22, 2023Complete Blockage; Complete Blockage
REPORTEDLY, ON (B)(6) 2020, THIS PATIENT UNDERWENT SURGICAL TREATMENT FOR A DISTAL AORTIC OCCLUSION WHICH CAUSED LOWER LIMB ISCHEMIA. A GORE-TEX® STRETCH VASCULAR GRAFT WAS USED IN THIS PROCEDURE. REPORTEDLY, ON (B)(6) 2022, AFTER 2 YEARS AND 2 MONTHS, A PART OF THE GRAFT WAS EXPLANTED DURING A NEW SURGICAL PROCEDURE DUE TO STENOSIS.
Patient problems: Stenosis
MAUDE report 16589329 ↗InjuryMar 22, 2023Microbial Contamination of Device; Microbial Contamination of Device
REPORTEDLY, ON (B)(6) 2007, THIS PATIENT UNDERWENT AN AXILOFEMORAL BYPASS PROCEDURE IN ORDER TO TREAT A LEFT LOWER LIMB ISCHEMIA (POST RADIOTHERAPY). ACCORDING TO RECORDS ON (B)(6) 2022 AFTER ABOUT 14 YEARS AND 8 MONTHS, THE PROSTHESIS WAS EXPLANTED DUE TO AN INFECTION (CANDIDA ALBICANS).
Patient problems: Fungal Infection
MAUDE report 16589284 ↗InjuryNov 3, 2020Contamination; Contamination
IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A BILATERAL CRITICAL LIMB ISCHEMIA. AN AXILLO-BI-FEMORAL BYPASS WAS MADE ON (B)(6) 2019 USING A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED AXILLOBIFEMORAL REMOVABLE RINGED. IT WAS STATED THAT ON (B)(6) 2019 THE AXILLO-BI-FEMORAL BYPASS WAS REMOVED AND REPLACED BY AN ALLOGRAFT BECAUSE OF AN INFECTION TO E. COLI, KLEBSIELLA PNEUMONIA AND STENOTROPHOMONAS MELOPHILIA.
Patient problems: Unspecified Infection
MAUDE report 10778492 ↗
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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