FDA-Device2023-02-08Class II
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
W L Gore & Associates, Inc.
Hazard
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Sold states
US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Affected count
14
Manufactured in
3750 W Kiltie Ln, N/A, Flagstaff, AZ, United States
Products
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2023Don't want to check this manually?
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