GORE PROPATEN Vascular Graft H080040ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASCULAR GRAFT SW 8mmX40cm Heparin · Class 2 · Implant
All models of GORE PROPATEN Vascular Graft (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132605873), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 death.
The most frequently reported specific device problem is “Material Separation” (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 Separation1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 27, 2020Material Separation; Material Separation
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 AN 8MM GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED AS A BYPASS, COMMON ILIAC TO DISTAL SFA. ON (B)(6) 2020 THE PHYSICIAN PERFORMED A RE-EXPLORATION AS A RESULT OF AN IDENTIFIED OCCLUSION WITHIN THE GRAFT. THE DOCTOR PERFORMED A GRAFT THROMBECTOMY AS WELL AS REVISION OF THE DISTAL ANASTOMOSIS, EXTENDING TREATMENT BY SEWING A SECOND GRAFT TO THE DISTAL ANASTOMOSIS TO THE POPLITEAL BELOW KNEE POSITION. ON (B)(6) THE GRAFT TO GRAFT ANASTOMOSIS DISRUPTED. ACCORDING TO THE DOCTOR, THE PATIENT BLED OUT VERY RAPIDLY AND EXPIRED.
Patient problems: Death
MAUDE report 9764624 ↗
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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