W L Gore recalls specific GORE VIABIL Short Wire Biliary Endoprosthesis models due to incorrect labeling that could lead to improper medical use. Affected units have wrong dimensions and drainage features.
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).
W L Gore is recalling certain GORE VIABIL Short Wire Biliary Endoprosthesis devices because they were incorrectly labeled. This could lead to improper medical use if the device is not used as intended, potentially causing complications during biliary duct procedures.
The recalled devices were labeled as 10 mm diameter x 10 cm with no drainage holes, but they actually have 10 mm diameter x 7 cm with drainage holes. This mismatch could cause improper placement during medical procedures, potentially leading to complications in the biliary duct.
Medical professionals who use the GORE VIABIL Short Wire Biliary Endoprosthesis for biliary duct procedures are most at risk. Patients receiving these devices may be affected if the incorrect labeling leads to improper use.
Check for the model number VSWVN1010 on the device packaging or label. The lot numbers 30965053 through 30965065 are also associated with this recall.
Look for the model number VSWVN1010 and lot numbers 30965053 through 30965065 on the device packaging or label.
The device is 10 mm diameter x 7 cm with transmural drainage holes, but was incorrectly labeled as 10 mm diameter x 10 cm without drainage holes.
Check for the model number VSWVN1010 and lot numbers 30965053 through 30965065 on the device packaging or label.
The recall does not specify a remedy, so contact the manufacturer for guidance on next steps.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-2914-2026 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-2914-2026 from W L Gore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
