GORE VIABAHN Endoprosthesis VBC071002Recalls & reported problems
W. L. Gore & Associates, Inc. · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis (26)
Data updated Oct 16, 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 00733132614530), received between Sep 4, 2018 and Sep 4, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Premature Activation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2018Premature Activation; Premature Activation
IT WAS REPORTED TO GORE THAT THE PATIENT HAD A STENOSIS OF THE LEFT BRACHIAL ARTERY, SINCE THE STENOSIS WAS NOT IMPROVED AFTER PTA TREATMENT BY A BALLOON, THE PHYSICIAN USED A GORE® VIABAHN® ENDOPROTHESIS FOR FURTHER TREATMENT. THE VIABAHN® DEVICE WAS ADVANCED THROUGH A 8FR TERUMO SHEATH OVER A 26 CM 0.035 TERUMO STIFF GUIDE WIRE TO THE TARGET LESION AND INITIATED DEPLOYMENT. HOWEVER, THE DEPLOYMENT LINE WAS REPORTEDLY STUCK IN THE SECOND LAYER ZIPPER AND THE DEVICE WAS EXPANDED AROUND 5 MM IN THE DISTAL, THE DEPLOYMENT COULD NOT CONTINUE. THE DEVICE WAS RETRACTED OUT OF THE PATIENT THROUGH THE SHEATH AND A NEW VIABAHN® DEVICE WAS USED TO CONTINUE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7841128 ↗
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- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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