GORE-TEX Stretch Vascular Graft SA2404Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT SW 24mmX40cm · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132611744), received between Dec 11, 2023 and Dec 11, 2023 — classified as 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
- Partial Blockage1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2023Partial Blockage; Partial Blockage
THE FOLLOWING WAS REPORTED TO GORE: MY CHILD WAS IMPLANTED WITH A ¿MASA VALVE¿ IN 2017 BUILT WITH THE OFF LABEL USE OF GORETEX STRETCH GRAFT AND PRECLUDE PERICARDIAL MEMBRANE. THE VALVE FAILED IN 2021. MULTIPLE ISSUES WERE IDENTIFIED BY THE SURGEON WHO REMOVED THE MASA VALVE, ONE: THE STITCHING OF THE SUTURES OF A LEAFLET TEARING AND THE LEAFLET ¿WAS FLOPPING IN THE WIND¿ WOULD YOU BE ABLE TO HELP MY SON AND I FILE A MAUDE ADVERSE EVENT REPORT? IT IS NOT YOUR PRODUCT THAT FAILED BUT THE OFF LABEL USE BY THE SURGEONS WHO FAILED TO GIVE INFORMED CONSENT THAT FAILED MY CHILD. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 6, 2023: DATE OF IMPLANT (B)(6), 2017. PATIENT HAD CHF IN (B)(6) 2022. VALVE HAD FAILED FEBRUARY 2022, LEAFLETS SUTURES HAD COME LOOSE "FLOPPING" IN THE WIND, ALSO CALCIUM BUILDUP AND STENOSIS OF THE CONDUIT. THE DEVICES WERE EXPLANTED ON (B)(6), 2022. IT WAS REPORTED IT WAS A ROSS PROCEDURE. REGURGITIVE AORTIC VALVE - SURGEON RECOMMENDED MASA VALVE IN PLACE OF PULMONARY VALVE. ADDITIONAL NOTE: IT WAS REPORTED ON DECEMBER 7, 2023 THAT THE PATIENT IS DOING WELL.
Patient problems: Stenosis
MAUDE report 18305058 ↗
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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