Device product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Z-1048-2023
Product summary
- Event
- Event 91380
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-1048-2023
Official wording
Reason: 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.
Code information: UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
Distribution pattern: US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Derived failure modes
-
Unknown
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.