GORE PROPATEN Vascular Graft HAX02ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASC GRAFT SW RR AXBI 8mmX90cm 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
- 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 00733132617692), received between Oct 22, 2019 and Jan 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Bacterial Infection1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2023, A PATIENT REPORTEDLY UNDERWENT TREATMENT FOR PERIPHERAL ARTERIAL DISEASE (OCCLUDED DISTAL AORTA AND BILATERAL COMMON ILIAC ARTERIES) WITH DEBILITATING SHORT DISTANCE CLAUDICATION AND RIGHT LEG WOUNDS, WHERE A GORE® PROPATEN® VASCULAR GRAFT WAS USED IN AN AXILLO-BIFEMORAL BYPASS WITH BILATERAL FEMORAL ENDARTERECTOMY PROCEDURE. IT WAS ALLEGED THERE WAS NO INFECTION PRESENT AT THE TIME OF THE SURGERY. ON (B)(6), 2023 (53 DAYS POST INITIAL SURGERY), THE PATIENT REPORTEDLY PRESENTED AT THE HOSPITAL WITH PAIN IN LOWER BACK, FEVER, AND SOME DISCHARGE FROM RIGHT GROIN INCISION. ON (B)(6) 2023, THE PATIENT UNDERWENT EMERGENCY EXPLORATORY SURGERY. IT WAS REPORTED, DURING THE PROCEDURE, AN UNINCORPORATED PORTION OF THE GRAFT THAT APPEARED TO BE INFECTED (SIGNS OF PURULENCE AND DISRUPTED SUTURE LINE) WAS EXPLANTED. THE REMAINING GRAFT ON THE RIGHT SIDE AND THE ENTIRE GRAFT ON THE LEFT SIDE OF THE PATIENT WERE NOT EXPLANTED. ON (B)(6) 2024 THE PATIENT WAS REPORTEDLY DISCHARGED AND TRANSFERRED TO ANOTHER FACILITY. ON (B)(6) 2024. THE PATIENT WAS ALLEGEDLY READMITTED TO THE FIRST HOSPITAL AND BLOODWORK CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS AUREUS IN SYSTEM, INDICATING ON-GOING
Patient problems: Bacterial Infection
MAUDE report 21242741 ↗InjuryOct 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A GORE® PROPATEN® VASCULAR GRAFT (STANDARD-WALLED, AXILLOBIFEMORAL, REMOVABLE RINGED) WAS IMPLANTED USING A GORE TUNNELER. AROUND (B)(6) 2019 (REPORTED AS 6-8 WEEKS AGO), PATIENT RECEIVED TREATMENT DUE TO SEROMA. CLEAR FLUID WAS DRAINED. ANOTHER INTERVENTION WAS PERFORMED AFTER (B)(6) (DATE UNSPECIFIED) AND CLEAR FLUID WAS DRAINED AGAIN. AS REPORTED, FLUID WAS TESTED EACH TIME. CULTURES WERE NEGATIVE FOR INFECTION AND THERE WAS NO BLOOD IN THE ASPIRATED FLUID. ON (B)(6) 2019, PATIENT PRESENTED WITH SEROMA AND CLEAR FLUID WAS DRAINED AGAIN. DURING THIS INTERVENTION, THE VASCULAR GRAFT WAS RELINED ALMOST ENTIRELY WITH SEVERAL GORE® VIABAHN® ENDOPROSTHESES. BEFORE IMPLANTATION, CAT SCAN MEASUREMENTS WERE TAKEN TO ENSURE CORRECT SIZING. IT WAS REPORTED ONLY A 4 CM SEGMENT WAS LEFT UNLINED. A DRAINAGE TUBE WAS LEFT IN PLACE. PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE PROCEDURE.
Patient problems: Seroma
MAUDE report 9221646 ↗
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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