GORE-TEX Vascular Graft SRRT06030040LRecalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT TW RR 6mmX40cm 30cm Rings · 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
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132612314), received between Apr 30, 2024 and Jan 27, 2025 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Partial 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Partial Blockage1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Obstruction/Occlusion1
- Reduced Blood Flow1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY: UNEXPECTED DEATH, POSSIBLY RELATED TO AV (ARTERIOVENOUS) GRAFT HEMORRHAGE AT ACCESS SITE. PATIENT WAS FOUND UNRESPONSIVE IN ROOM, HEMORRHAGE EVIDENT. DNR (DO-NOT-RESUSCITATE ORDER). 2200-A:-OTHER USED TO CAPTURE HEMORRHAGE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21246375 ↗InjuryApr 30, 2024Partial Blockage; Partial Blockage
THE FOLLOWING WAS REPORTED TO GORE: ON MAY 9, 2022 A 6MM GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED AS PART OF A BYPASS BETWEEN THE LEFT SUBCLAVIAN ARTERY AND THE LEFT COMMON CAROTID ARTERY. THE PATIENT WAS FURTHER TREATED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) IN ZONE 1. ON (B)(6) 2022 DURING THE PATIENT'S ONE MONTH FOLLOW UP, IT WAS NOTICED THAT THE GRAFT HAD OCCLUDED. A BILATERAL UPPER EXTREMITY AND LOWER EXTREMITY ARTERIAL DOPPLER WERE PERFORMED. THE LEFT UPPER EXTREMITY ARTERIAL DOPPLER SHOWS LEFT SUBCLAVIAN ARTERIAL DISEASE WITH MODERATE FLOW REDUCTION TO THE WRIST. THE PHYSICIAN EVALUATED THE PATIENT WITH NO INTERVENTION NECESSARY. IT WAS NOTICED THAT THE PATIENT'S DECREASED FLOW IN THE LEFT SUBCLAVIAN IS CONSISTENT WITH THE KNOWN OCCLUSION OF THE LEFT CAROTID STENT THAT WAS IDENTIFIED OUTPATIENT.
Patient problems: Obstruction/Occlusion; Reduced Blood Flow
MAUDE report 19217875 ↗
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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