GORE-TEX Stretch Vascular Graft S0508Recalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASCULAR GRAFT SW 5mmX80cm · 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 00733132611256), received between Oct 27, 2021 and Oct 27, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR A FISTULA IN THE ARM WITH A GORE-TEX® STRETCH VASCULAR GRAFT NON-RINGED. IT WAS STATED THAT ON (B)(6) 2021 THE PHYSICIAN IMPLANTED A GORE-TEX® STRETCH VASCULAR GRAFT TO REDUCE THE BLOOD FLOW OF A FISTULA. SOME DAYS LATER THE PATIENT PRESENTED WITH A LYMPHOCELE. IT WAS REPORTED THAT A RE-INTERVENTION TOOK PLACE ON (B)(6) 2021 TO DRAIN THE LYMPHOCELE. HEREBY THE PHYSICIAN REALIZED THAT THE WALL OF THE GRAFT WAS PERMEABLE ALL ALONG. IT WAS STATED THAT THE PHYSICIAN DECIDED TO REPLACE THE GRAFT WHICH WAS PERFORMED ON (B)(6) 2021. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Seroma
MAUDE report 12702589 ↗
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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