GORE VIABAHN Endoprosthesis VBCR130502ARecalls & reported problems
W. L. Gore & Associates, Inc. · GORE VIABAHN Endoprosthesis 13mmx5cm 10Fr 120cmCath · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis (26)
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 00733132645909), received between Feb 7, 2025 and Feb 7, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Biocompatibility2
Patient problems
- Hypersensitivity/Allergic reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2025Biocompatibility; Biocompatibility
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ARTERIOVENOUS (AV) ACCESS GRAFT REVISION OF A NON-GORE GRAFT WITH TWO GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE). IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT RETURNED TO THE HOSPITAL WITH A SEVERE ALLERGIC REACTION. THE PATIENT SPENT THREE DAYS IN THE HOSPITAL RECEIVING MEDICAL TREATMENT. THE PHYSICIAN SUSPECT THAT THE ALLERGIC REACTION WAS DUE TO THE STERILIZATION PROCESS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21337840 ↗InjuryFeb 7, 2025Biocompatibility; Biocompatibility
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ARTERIOVENOUS (AV) ACCESS GRAFT REVISION OF A NON-GORE GRAFT WITH TWO GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE). IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT RETURNED TO THE HOSPITAL WITH A SEVERE ALLERGIC REACTION. THE PATIENT SPENT THREE DAYS IN THE HOSPITAL RECEIVING MEDICAL TREATMENT. THE PHYSICIAN SUSPECT THAT THE ALLERGIC REACTION WAS DUE TO THE STERILIZATION PROCESS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21337194 ↗
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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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