W L Gore & Associates, Inc.: Stents, Drains And Dilators For The Biliary Ducts
- Recalling firm
- W L Gore & Associates, Inc.
- 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.
- Reason
- 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of GA and RI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d68e39ef-cb19-4be1-bfb8-b61f606998d6