W L Gore recalls GORE VIABIL Short Wire Biliary Endoprosthesis Model VSWVN1006 due to incorrect labeling that could lead to improper medical use. Affected units have specific serial numbers and catalog codes.
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 a specific biliary stent model because it was incorrectly labeled. This could lead to improper medical use if the device is not used as intended. Patients should check if their device matches the described model and serial numbers.
The device was labeled incorrectly as a 10 mm diameter x 10 cm length without drainage holes when it is actually a 10 mm diameter x 7 cm device with drainage holes. This mismatch could cause improper placement or function during medical procedures, potentially leading to complications.
Patients who have the GORE VIABIL Short Wire Biliary Endoprosthesis Model VSWVN1006 with the listed serial numbers are most at risk. Medical professionals using this device for bile duct procedures may also be affected.
Check for the model number VSWVN1006 on the device packaging or label. Look for the specific serial numbers listed: 30970948 through 30970960. The incorrect labeling affects the device's intended use in bile duct procedures.
Look for the model number VSWVN1006 and serial numbers 30970948 to 30970960 on the device packaging or label.
The device was incorrectly labeled as a 10 mm diameter x 10 cm length without drainage holes when it is actually a 10 mm diameter x 7 cm device with drainage holes. This could lead to improper medical use.
Check the device label for the model number VSWVN1006 and serial numbers 30970948 to 30970960. If you have these, contact W L Gore for further instructions.
The recall does not specify a risk of serious injury. The hazard is related to incorrect labeling that could affect medical use, but no specific injury mechanism is described.
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-2915-2026 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-2915-2026 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.
