GORE VIABAHN Endoprosthesis with Heparin VBHR081001ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 35 RO 8mmX10cm 8Fr 75cmCath · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis with Heparin (62)
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 00733132623129), received between May 20, 2025 and May 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN ANEURYSM IN THE RIGHT HYPOGASTRIC ARTERY WITH A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE). AFTER THE VSX DEVICE WAS SUCCESSFULLY DELIVERED, THE PHYSICIAN FELT RESISTANCE DURING THE REMOVAL OF THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH (MANUFACTURER AND SIZE UNKNOWN). AFTER THE REMOVAL OF THE DELIVERY CATHETER IT WAS OBSERVED TO HAVE BEEN BROKEN AT THE DISTAL SHAFT. THE PHYSICIAN USED A SNARE TO REMOVE THE REMAINDER OF THE DELIVERY CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054355 ↗
Other Stent, Superficial Femoral Artery devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page