Gore Viabil Biliary Endoprosthesis Recalled for Length Discrepancy
W.L. Gore & Associates is recalling 61 Gore Viabil Biliary Endoprosthesis devices because a complaint reported a device appeared shorter than its labeled length.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential labeling or manufacturing discrepancy (length) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
W.L. Gore & Associates, Inc. is recalling 61 units of the GORE VIABIL Biliary Endoprosthesis. These medical devices, which include stents, drains, and dilators for the biliary ducts, are intended for the palliation of malignant strictures in the biliary tree. The specific catalogue numbers involved are VH1008040, VH1010040, VN1010040, and VN0808200.
The recall was initiated after the manufacturer's post-market surveillance team received a complaint stating that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the length indicated on its label. The affected devices were distributed worldwide, including nationwide in the United States and in Portugal and Italy.
Healthcare providers and patients should check their inventory and patient records for devices matching the specific serial numbers listed in the recall notice. If a device is found, it should be removed and returned to the manufacturer according to their instructions.
The recalled product
- Product
- GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
- Manufacturer
- W.L. Gore & Associates, Inc.
- Affected units
- 61
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Number: 22552467
- 22552468
- 22552469
- 22552470
- 22552471
- 22552472
- 22552473
- 22552474
- 22552475
- 22552476
- 22552477
- 22552478
- 22552479
- 22552480
- 22552481
- 22552482
- 22552483
- 22552484
- 22552756
- 22552757
Distribution
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