FDA recall, , Moderate risk
GORE VIABIL Short Wire Biliary Endoprosthesis
The GORE VIABIL biliary endoprosthesis may be mislabeled, with a 10 mm x 7 cm device labeled as a 10 mm x 10 cm device.
Summary by Recall Canary from the FDA notice
What happened
W L Gore & Associates, Inc. of Flagstaff, Arizona, recalled the GORE VIABIL Short Wire Biliary Endoprosthesis, Model Nos. VSWVN1010 and VSWVN1006, because 10 mm diameter x 7 cm devices with transmural drainage holes were incorrectly labeled as 10 mm diameter x 10 cm length devices without those holes. The recall began May 22, 2026, and was added to the FDA's Enforcement Report on August 7, 2026. The products were distributed in Georgia and Rhode Island.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Gore Viabil Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- UDI-DI
- 00733132638888
- 30965053
- 30965054
- 30965055
- 30965056
- 30965057
- 30965058
- 30965059
- 30965060
- 30965061
- 30965062
- 30965063
- 30965064
- 30965065
Gore Viabil Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- UDI-DI
- 00733132638796
- 30970948
- 30970949
- 30970950
- 30970951
- 30970952
- 30970953
- 30970954
- 30970955
- 30970956
- 30970957
- 30970958
- 30970959
- 30970960
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Georgia and Rhode Island.
- Company
- W L Gore & Associates, Inc.Flagstaff, Arizona
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99143
- Recall numbers
- Z-2914-2026 to Z-2915-2026
All recalls from W L Gore & Associates, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
