Device recall

Z-2914-2026: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible…

FDA device recall · Class II · W L Gore & Associates, Inc.

Key facts

Recall number (Z-number) Z-2914-2026
Recall event 99143
Product 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 be obstructed.
Product code FGE
Recalling firm W L Gore & Associates, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K170740
FEI number 2017233

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)