W.L. Gore & Associates, Inc.: GORE VIABIL Biliary Endoprosthesis Recalled for Potential Mislabeled Drainage Holes

Agency Publication Date: February 22, 2024

Summary

W.L. Gore & Associates, Inc. is recalling 24 units of the GORE VIABIL Short Wire Biliary Endoprosthesis because devices may be mislabeled regarding the presence of transmural drainage holes. This medical device is a self-expanding tube used to keep blocked bile ducts open; however, some devices with holes may be labeled as having none, or those without holes may be labeled as having them. This defect can lead to serious medical complications including unplanned device removal, biliary infections (cholangitis or cholecystitis), pain, or the need for secondary procedures.

Risk

The use of an incorrectly labeled biliary stent can result in inadequate bile drainage or improper placement, potentially leading to severe gallbladder or bile duct inflammation and the need for immediate surgical intervention.

What You Should Do

Immediately check your medical inventory for GORE VIABIL Short Wire Biliary Endoprosthesis (10 mm x 8 cm) with Catalog Numbers VSWVH1008 or VSWVN1008.
Identify affected units by matching UDI-DI 00733132638802 with serial numbers 27063943, 27063944, 27063949, 27063950, 27063952, or 27063953.
Identify additional affected units by matching UDI-DI 00733132638871 with serial numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, or 27063428.
If you have an affected device, do not use it and contact W.L. Gore & Associates, Inc. at 301 Airport Rd, Elkton, MD 21921 for instructions on returning or replacing the mislabeled units.
Patients who have recently undergone a biliary stent procedure should contact their healthcare provider if they experience unusual pain, fever, or signs of infection.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Manufacturer notification and device return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GORE VIABIL Short Wire Biliary Endoprosthesis (10 mm x 8 cm, with holes)

Model / REF:

VSWVH1008

UPC Codes:

00733132638802

Lot Numbers:

Serial Numbers: 27063943, 27063944, 27063949, 27063950, 27063952, 27063953

Product: GORE VIABIL Short Wire Biliary Endoprosthesis (10 mm x 8 cm, no holes)

Model / REF:

VSWVN1008

UPC Codes:

00733132638871

Lot Numbers:

Serial Numbers: 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93882

Status: Active

Manufacturer: W.L. Gore & Associates, Inc.

Sold By: Hospital supply chains; Medical device distributors

Manufactured In: United States

Units Affected: 24

Distributed To: Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your medical inventory for GORE VIABIL Short Wire Biliary Endoprosthesis (10 mm x 8 cm) with Catalog Numbers VSWVH1008 or VSWVN1008.

Identify affected units by matching UDI-DI 00733132638802 with serial numbers 27063943, 27063944, 27063949, 27063950, 27063952, or 27063953.

Identify additional affected units by matching UDI-DI 00733132638871 with serial numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, or 27063428.

If you have an affected device, do not use it and contact W.L. Gore & Associates, Inc. at 301 Airport Rd, Elkton, MD 21921 for instructions on returning or replacing the mislabeled units.

Patients who have recently undergone a biliary stent procedure should contact their healthcare provider if they experience unusual pain, fever, or signs of infection.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Affected Products

Product: GORE VIABIL Short Wire Biliary Endoprosthesis (10 mm x 8 cm, with holes)

Model / REF:

VSWVH1008

UPC Codes:

00733132638802

Lot Numbers:

Serial Numbers: 27063943, 27063944, 27063949, 27063950, 27063952, 27063953

Product: GORE VIABIL Short Wire Biliary Endoprosthesis (10 mm x 8 cm, no holes)

Model / REF:

VSWVN1008

UPC Codes:

00733132638871

Lot Numbers:

Serial Numbers: 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428