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.
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. VSWVN1010. 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: VSWVN1010 / 00733132638888Model VSWVN1010 / 00733132638888Model Lot Serial No. 30965053Model 30965054Model 30965055Model 30965056Model 30965057Model 30965058Model 30965059Model 30965060Model 30965061Model 30965062Model 30965063Model 30965064UPC 00733132638888Would you have heard about this one?
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