GORE-TEX Vascular Graft SRD06005045LRecalls & reported problems
W. L. Gore & Associates, Inc. · STR RG 6MM 5CM RS X 45CM STRETCH · 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
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132612260), received between Oct 18, 2019 and Oct 18, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT FEMORAL ARTERY LOOP PROCEDURE WITH A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED FIXED RINGED. THE DEVICE WAS REPORTEDLY USED FOR THE APPLICATION OF AV ACCESS. IT IS UNKNOWN IF THE DEVICE WAS PRE-CANNULATED FOR AV ACCESS. THERE WAS REPORTEDLY NO PRE-EXISTING INFECTION AT IMPLANT SITE. ON (B)(6) 2019, THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO INFECTION. THE PHYSICIAN REPORTEDLY STATED IT IS UNKNOWN IF THE CAUSE OF THE INFECTION IS ATTRIBUTED TO THE GORE DEVICE.
Patient problems: Unspecified Infection
MAUDE report 9211190 ↗InjuryOct 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED FIXED RINGED IN THEIR RIGHT FEMORAL ARTERY. THE DEVICE WAS REPORTEDLY USED FOR THE APPLICATION OF AV ACCESS. IT IS UNKNOWN IF THE DEVICE WAS PRE-CANNULATED FOR AV ACCESS. THERE WAS REPORTEDLY NO PRE-EXISTING INFECTION AT IMPLANT SITE. ON (B)(6) 2019, THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO INFECTION. THE PHYSICIAN REPORTEDLY STATED IT IS UNKNOWN IF THE CAUSE OF THE INFECTION IS ATTRIBUTED TO THE GORE DEVICE.
Patient problems: Unspecified Infection
MAUDE report 9210759 ↗
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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