Lower riskMedical device recall · FDA · Published April 5, 2021
Gore Biliary Stents Shorter Than Labeled: Recall for Medical Device
Gore recalls biliary endoprosthesis stents and drains that may be shorter than labeled, potentially causing improper placement in bile ducts. Affected units include specific catalog and serial numbers.
“Gore Biliary Stents Shorter Than Labeled: Recall for Medical Device.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62859-gore-biliary-stents-shorter-than-labeled-recall-for-medical-device. Based on FDA recall #Z-1593-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1593-2021%22&limit=1).
The FDA announced on April 5, 2021, that W.L. Gore & Associates, Inc. is recalling GORE VIABIL Biliary Endoprosthesis devices due to a potential length discrepancy. The agency classified the recall as Class II and voluntary.
Serial numbers: 22552467 through 22552782 and 22613929 through 22613931
Quantity: 61 devices
The hazard
The recall stems from a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than its labeled length. The FDA reported no specific incidents or injuries associated with this hazard in the record.
Context
GovInfoNow's records show W.L. Gore & Associates, Inc. has issued 18 other recalls since September 25, 2017. Recent brand recalls include a May 22, 2026 notice for incorrect labeling of GORE VIABIL Short Wire Biliary Endoprosthesis devices and a May 19, 2026 recall regarding catheter separation in Thoracic Branch Endoprosthesis components. Other recent recalls of similar products include Bard Ureteral Stent Kit Recall (November 6, 2025), Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (November 6, 2025), Cook Rupsch-Uchida Liver Access Sets Recall (November 26, 2025), and W L Gore ACUSEAL Vascular Graft Recall (August 26, 2025).
How to tell if you have this one
Check for catalog numbers VH1008040, VH1010040, VN1010040, VN0808200. Look for serial numbers starting with 22552467 through 22552782 and 22613929 through 22613931.
Brand
Gore
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the catalog number and serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kansas, Maryland, Minnesota, Nebraska, New York, Oklahoma, Rhode Island, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1593-2021 (April 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1593-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.