GORE VIABAHN Endoprosthesis VBCR071502ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO 35 RO 7mmX15cm 8Fr 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623488), received between May 9, 2024 and May 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2024Premature Activation; Premature Activation
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED TO RELINE AN ARTERIOVENOUS ACCESS GRAFT DURING TREATMENT OF STENOSIS. DURING THE ADVANCEMENT OF THE VSX DEVICE THE PHYSICIAN FELT RESISTANCE GOING THROUGH STENOSIS IN THE PREVIOUSLY IMPLANTED ARTERIOVENOUS ACCESS GRAFT (UNKNOWN MANUFACTURER). AFTER THE PHYSICIAN FELT RESISTANCE, HE CONTINUED TO ADVANCE THE VSX DEVICE AND FELT THE DEVICE UNINTENTIONALLY DEPLOY. WITH PREMATURE DEVICE EXPANSION THE PHYSICIAN REMOVED THE DELIVERY CATHETER AND WAS NOT CONCERNED ABOUT THE POSITION OF THE DEVICE. THE PHYSICIAN DID NOT FEEL LIKE THE PATIENT NEEDED ANY ADDITIONAL DEVICES AT THIS TIME AND THE CASE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280316 ↗
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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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