GORE VIABAHN Endoprosthesis with Heparin VBHR060202ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 35 RO 6mmX2.5cm 7Fr120cmCath · 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 00733132622726), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2020Migration; Migration
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY IN THE RENAL ARTERY AND UNDERWENT TREATMENT USING A GORE® VIABAHN® ENDOPROSTHESIS (VSX) AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN DEPLOYED THE FIRST VBX DEVICE APPROXIMATELY 1 CM SHALLOW IN THE TREATMENT ZONE. THEN THE PHYSICIAN EXTENDED THE PLACED ENDOPROSTHESIS WITH AN ADDITIONAL VBX DEVICE. THE PHYSICIAN THEN DEPLOYED A VSX DEVICE TO LINE BOTH VBX DEVICES. WHILE ATTEMPTING TO REMOVE THE ROSEN GUIDEWIRE, THE WIRE DISLODGED ALL OF THE STENTS AND PULLED THE VBX & VSX DEVICES OUT OF THE VESSEL. THE PHYSICIAN WAS THEN ABLE TO SNARE ALL THREE DEVICES AND CAPTURE THE DEVICES FOR REMOVAL WITH A LARGE BORE SHEATH. A FEMORAL CUT DOWN WAS THEN USED TO REMOVE ALL SNARED DEVICES FROM PATIENT. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: No Code Available
MAUDE report 10491455 ↗
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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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