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W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Recalled November 2, 2022 · FDA recall Z-0136-2023 · W L Gore & Associates
Hazard
Due to manufacturing records (Release Test Results) indicating "Failed". · FDA Class II
Units
98 units
Sold at
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.
Description
Due to manufacturing records (Release Test Results) indicating "Failed".
Product
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Manufacturer(s)
W L Gore & Associates, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →