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U.S. Department of Health and Human Services

Class 2 Device Recall GORE VIBIL Biliary Endoprosthesis

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  Class 2 Device Recall GORE VIBIL Biliary Endoprosthesis see related information
Date Initiated by Firm April 05, 2021
Create Date May 14, 2021
Recall Status1 Terminated 3 on January 16, 2024
Recall Number Z-1593-2021
Recall Event ID 87699
510(K)Number K081184  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
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.
Code Information Serial Number:  22552467, 22552468, 22552469, 22552470, 22552471, 22552472, 22552473, 22552474, 22552475, 22552476, 22552477, 22552478, 22552479, 22552480, 22552481, 22552482, 22552483, 22552484, 22552756, 22552757, 22552758, 22552759, 22552760, 22552761, 22552762, 22552763, 22552764, 22552765, 22552766, 22552767, 22552768, 22552769, 22552770, 22552771, 22552772, 22552773, 22552774, 22552775, 22552776, 22552777, 22552778, 22552779, 22552780, 22552781, 22552782, 22613929, 22613930, 22613931 
Recalling Firm/
Manufacturer		 W.L. Gore & Associates, Inc.
301 Airport Rd
Elkton MD 21921-4130
For Additional Information Contact MPD Customer Care
800-528-8763
Manufacturer Reason
for Recall		 The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
FDA Determined
Cause 2		 Process change control
Action On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.
Quantity in Commerce 61 devices
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV.
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