Recall Z-1593-2021— W.L. Gore & Associates, Inc.
Class II · Terminated
Class II FDA medical device recall by W.L. Gore & Associates, Inc., initiated 2021-04-05, terminated 2024-01-16. It names one FDA 510(k) clearance: K081184. 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.. Reason: The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length..
- Recalling firm
- W.L. Gore & Associates, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-05
- Terminated
- 2024-01-16
- Firm location
- Elkton, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
Data sourced from openFDA. This site is unofficial and independent of the FDA.