Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1593-2021·Announced 2021-05-26

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category: Medical Device — Biliary Endoprosthesis
Hazard: mis-labeling
manufacturing-defect
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

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Same manufacturer · W.L. Gore & Associates, Inc.

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