GORE VIABIL Biliary Endoprosthesis VH1008040Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE VIABIL BILIARY ENDO 10mmX8cm 10Fr · Class 2 · Implant
All models of GORE VIABIL Biliary Endoprosthesis (11)
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 00733132615490), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
1 other recall cover devices cleared under the same FDA submission (K041423, K081184); they may or may not involve this specific model.
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
- Migration1
- Obstruction of Flow1
Patient problems
- Abdominal Pain1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Obstruction of Flow; Migration
Patient problems: Abdominal Pain; Obstruction/Occlusion
MAUDE report 50872655 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041423, K081184. One submission often covers many models, so check the product and lot details in each record.
- Z-1593-2021 · Apr 5, 2021 · TerminatedGORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for pa
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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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