FDA recall Z-0136-2023

W L Gore & Associates, Inc. · Class II · device

Product

GORE CARDIOFORM ASD Occluder. cardiovascular implant.

Reason for recall

Due to manufacturing records (Release Test Results) indicating "Failed".

Distribution

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.

Key facts

Status: Ongoing
Initiation date: 2022-09-21
Report date: 2022-11-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Flagstaff, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0136-2023