W. L. Gore recalls specific models of short wire biliary endoprosthesis with potential labeling errors that could lead to extended procedure times, unplanned removal, or infections. Affected units include catalog numbers VSWVH1008 and VSWVN1008 with specific serial numbers.
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
W. L. Gore is recalling certain short wire biliary endoprosthesis models due to a labeling error that may cause the device to be mislabeled as having transmural drainage holes when it doesn't. This could lead to longer surgeries, unplanned device removal, or infections. Patients using these devices should contact the manufacturer for guidance.
The devices may be mislabeled as having transmural drainage holes when they don't, or vice versa. This labeling error can cause extended procedure times, unplanned device removal, secondary procedures, infections like cholangitis or cholecystitis, and pain.
Patients who have received the specific catalog numbers and serial numbers listed in the recall are affected. Medical professionals who use these devices during procedures are at higher risk due to potential complications.
Check for catalog numbers VSWVH1008 (10 mm x 8 cm with holes) or VSWVN1008 (10 mm x 8 cm without holes). Look for specific serial numbers listed in the recall notice.
Reach out to W. L. Gore for guidance on whether your device is affected and next steps.
The devices may be mislabeled as having transmural drainage holes when they don't, or vice versa.
Potential risks include extended procedure times, unplanned device removal, secondary procedures, infections like cholangitis or cholecystitis, and pain.
Check for catalog numbers VSWVH1008 (10 mm x 8 cm with holes) or VSWVN1008 (10 mm x 8 cm without holes) and specific serial numbers listed in the recall notice.
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-1179-2024 — W. L. Gore W. L. Gore Hello, I own a W. L. Gore that is covered by recall Z-1179-2024 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.
