The Food & Drug Administration issued a recall for Arstasis Inc.’s arterial access device.
Components of the Redwood City, Calif.-based company’s One Access System could fracture or separate during surgical procedures, which could lead to patient harm, according to the watchdog agency.
The device is designed to provide surgical access to blood vessels in femoral artery catheterization procedures. It also assists care providers in stopping the bleeding involved in the procedure, the FDA said.