GORE VIABAHN Endoprosthesis VBCR070202ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO 35 RO 7mmX2.5cm 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 00733132623426), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionDec 11, 2018Material Fragmentation; Material Fragmentation
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IN A VOLUNTARILY SUBMITTED MEDWATCH, IT STATES THE FOLLOWING: ON (B)(6) 2018, A PATIENT WAS UNDERGOING FISTULOGRAM TREATMENT WITH THROMBECTOMY AND ANGIOPLASTY WITH STENT GRAFT DEPLOYMENT OF A LEFT ARM HEMODIALYSIS GRAFT. AFTER THE ARTERIAL PLUG AND RESIDUAL THROMBUS WERE REMOVED, THERE WAS STILL A RESIDUAL STENOSIS ACROSS THE VENOUS ANASTOMOSIS. A GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED OVER A .035" GUIDEWIRE TO TREAT THIS STENOSIS. FOLLOWING DEPLOYMENT, UPON REMOVAL OF THE DELIVERY CATHETER, IT WAS NOTICED THAT THE DISTAL END OF THE CATHETER WAS MISSING. FLUOROSCOPY REVEALED THAT THE FRACTURED TIP WAS STILL ON THE GUIDEWIRE. THE TIP WAS ABLE TO BE RETRIEVED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8152045 ↗
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- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
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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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