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W L Gore & Associates, Inc. Recall

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal pat

Updated May 22, 2026

W L Gore & Associates, Inc. is recalling GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal pat. Hazard: 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).

Is the W L Gore & Associates, Inc. recalled? Yes. This product was recalled by FDA on May 22, 2026. Details below.

What is recalled

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.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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).

Brands affected

W L Gore & Associates, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2914-2026
Classification
Class II
Recalled
May 22, 2026
Read the official notice

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