GORE INTERING Vascular Graft IRS47045LRecalls & reported problems
W. L. Gore & Associates, Inc. · INTERING VASC GRAFT STR SW IR 4-7mmX45cm 38cm Rings Tapered · Class 2 · Implant
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 00733132607204), received between Jun 6, 2022 and Jun 6, 2022 — 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
- Hematoma2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON DECEMBER 2, 2021, A GORE® INTERING® VASCULAR GRAFT WAS INTENDED FOR HEMODIALYSIS TREATMENT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH SEROMA. A GORE® INTERING® VASCULAR GRAFT WAS SEWN IN AS A INTERPOSITION GRAFT. ON APRIL 20, 2022, THE PATIENT PRESENTED WITH SEROMA. A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS ENDOVASCULARLY PLACED TO RELINE THE SECOND GORE® INTERING® VASCULAR GRAFT, FOR TREATMENT OF ULTRAFILTRATION. ULTRAFILTRATION WAS IDENTIFIED DURING THE PROCEDURE AFTER THE VSX DEVICE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, THE GORE® INTERING® VASCULAR GRAFT, AND VSX DEVICE WERE EXPLANTED. 2203-A:-OTHER CODE (POST-OPERATIVE FLUID LEAKAGE THROUGH VSX DEVICE WALL AFTER ESTABLISHMENT OF BLOOD FLOW).
Patient problems: Hematoma
MAUDE report 14604839 ↗InjuryJun 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® INTERING® VASCULAR GRAFT WAS INTENDED FOR HEMODIALYSIS TREATMENT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH SEROMA. A GORE® INTERING® VASCULAR GRAFT WAS SEWN IN AS A INTERPOSITION GRAFT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH SEROMA. A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS ENDOVASCULARLY PLACED TO RELINE THE SECOND GORE® INTERING® VASCULAR GRAFT, FOR TREATMENT OF ULTRAFILTRATION. ULTRAFILTRATION WAS IDENTIFIED DURING THE PROCEDURE AFTER THE VSX DEVICE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, THE GORE® INTERING® VASCULAR GRAFT, AND VSX DEVICE WERE EXPLANTED. (B)(4).
Patient problems: Hematoma
MAUDE report 14603491 ↗
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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