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 be obstructed.
W L Gore & Associates, Inc.
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). FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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 be obstructed.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796Model VSWVH1006 / 00733132638796Model Lot Serial No. 30970948Model 30970949Model 30970950Model 30970951Model 30970952Model 30970953Model 30970954Model 30970955Model 30970956Model 30970957Model 30970958Model 30970959UPC 00733132638796Would you have heard about this one?
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