W L Gore & Associates, Inc. — Class II: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expandi
W L Gore & Associates, Inc. initiated a Class II recall for the GORE VIABIL Short Wire Biliary Endoprosthesis because 7 cm devices with transmural drainage holes were incorrectly labeled as 10 cm devices without drainage holes.
This recall affects W L Gore & Associates, Inc., clinicians performing biliary stenting procedures, and regulatory/QA teams overseeing self-expanding endoprosthesis labeling.
The discrepancy between the labeled length and physical length, as well as the presence of unauthorized transmural drainage holes, suggests a failure in the labeling verification or packaging process. In a clinical setting, this error could lead to incorrect device sizing or unintended drainage characteristics during implantation.
Verify that internal labeling verification processes for biliary endoprostheses account for specific physical features like transmural drainage holes. Conduct an immediate inventory reconciliation to identify any units where the outer packaging label does not match the physical dimensions and features of the device.
Class II. 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).. 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.. Firm: W L Gore & Associates, Inc. (Flagstaff AZ United States). Status: Ongoing.
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