FDA-Device2022-11-02Class II
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
W L Gore & Associates, Inc.
Hazard
Due to manufacturing records (Release Test Results) indicating "Failed".
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.
Affected count
98 units
Manufactured in
3750 W Kiltie Ln, N/A, Flagstaff, AZ, United States
Products
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0136-2023Don't want to check this manually?
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