Reported May 26, 2021 · Terminated
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040,…
W.L. Gore & Associates, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W.L. Gore & Associates, Inc. · 301 Airport Rd · Elkton, MD · 21921-4130
Is this the product you have?
- GORE VIBIL Biliary Endoprosthesisstents, drains and dilators for the biliary ducts
- Catalogue numbers
VH1008040VH1010040VN1010040
- VN0808200 - Product Usageintended for palliation of malignant strictures in the biliary tree
- Lot codes and dates
- Serial Number
225524672255246822552469225524702255247122552472225524732255247422552475225524762255247722552478225524792255248022552481225524822255248322552484225527562255275722552758225527592255276022552761225527622255276322552764225527652255276622552767225527682255276922552770225527712255277222552773225527742255277522552776225527772255277822552779225527802255278122552782226139292261393022613931
- Serial Number
- Amount recalled
- 61 devices
Where it was sold
Why it was recalled
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
This product could cause temporary or reversible health problems — stop using it.
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