GORE VIABAHN Endoprosthesis with Heparin VBJ081002Recalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 18 8mmX10cm 7Fr120cm Cath · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132615384), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Partial Blockage1
Patient problems
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 31, 2022Partial Blockage; Deformation Due to Compressive Stress; Partial Blockage; Deformation Due to Compressive Stress
THE FOLLOWING WAS REPORTED TO GORE: A GORE® VIABAHN® ENDOPROSTHESIS (VSX) DEVICE WAS INTENDED FOR USE IN THE LEFT SUBCLAVIAN ARTERY FOR TREATMENT OF OCCLUSION. ON (B)(6) 2011, A GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY IMPLANTED TO TREAT OCCLUSION OF THE LEFT SUBCLAVIAN ARTERY. ON AN UNKNOWN DATE THE PATIENT HAD SWELLING IN HIS THE NECK. THE PATIENT WENT TO SEE DR. (B)(6) AND HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN PERFORMED. OCCLUSION WAS OBSERVED IN THE PREVIOUSLY IMPLANTED VSX DEVICE. ON (B)(6) 2022, THE PATIENT UNDERWENT A REINTERVENTION OF THE OCCLUDED VSX DEVICE. DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO PASS THE GUIDE WIRE (MANUFACTURER UNKNOWN) THROUGH THE DEVICE. AN ANGIOGRAM WAS PERFORMED AND IT WAS OBSERVED THAT THE VSX DEVICE WAS COMPRESSED BY BONE STRUCTURES. WITH THE INABILITY TO PASS THE WIRE, THE PATIENT WAS LEFT UNTREATED. A REINTERVENTION IS PLANNED FOR A LATER DATE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: Obstruction/Occlusion
MAUDE report 13404058 ↗
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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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