W L Gore & Associates, Inc.: GORE CARDIOFORM Septal Occluder, REF: GSX0030A

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA. Quantity: 14 Lot/code info: UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406

UPC codes

00733132631032

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.