GORE CARDIOFORM Septal Occluder, REF: GSX0030A
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.
US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2023