GORE VIABIL Biliary Endoprosthesis VSWVH0808Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K170740); 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.

Recalls naming this device

1. Sep 3, 2026Open, Classified

   The potential for the devices to be mislabeled with the incorrect length.

   Z-0158-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170740. One submission often covers many models, so check the product and lot details in each record.

• Z-2915-2026 · May 22, 2026 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b
• Z-2914-2026 · May 22, 2026 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b
• Z-1179-2024 · Jan 19, 2024 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes