GORE PROPATEN Vascular Graft H060040ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASCULAR GRAFT SW 6mmX40cm 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
- 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 00733132605811), received between Dec 5, 2018 and Jun 19, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
Patient problems
- No Code Available1
- Occlusion1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH A GORE® PROPATEN® VASCULAR GRAFT FOR AV ACCESS IN THE LEFT COMMON ILIAC ARTERY. ON AN UNKNOWN DATE, DELAMINATION OF THE GRAFT WAS REPORTEDLY IDENTIFIED. ON (B)(6), THE GORE® PROPATEN® VASCULAR GRAFT WAS SURGICALLY REMOVED FROM THE PATIENT IN MULTIPLE PIECES.
Patient problems: No Code Available
MAUDE report 10176855 ↗InjuryDec 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED TO GORE FROM THE HOSPITAL PURCHASING SUPERVISOR: A PATIENT HAD A 6MM GORE PROPATEN VASCULAR GRAFT PLACED ON (B)(6) 2018 IN THE FOREARM. VENOUS STENOSIS WAS NOTED AT THE GRAFT-VEIN ANASTOMOSIS APPROXIMATELY 2 MONTHS POST OP. AT THAT TIME THE DOCTOR OBSERVED THE AREA AROUND THE GRAFT BUBBLED WITH SEROUS FLUID. THE DOCTOR REPORTED THERE WAS NO OBVIOUS SIGN OF INFECTION. THE DOCTOR PLUGGED THE ARTERIAL LIMB TO THROMBOSE THE GRAFT. GRAFT REMOVAL IS PLANNED.
Patient problems: Occlusion; Seroma
MAUDE report 8133884 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page