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.
The agency tapped the action as a Class I recall, meaning it believes there’s a possibility the device could cause serious injury or death.
Arstasis sent a recall letter to customers Oct. 10, 2010. The FDA posted the recall on its website Feb. 9. The recall refers specifically to the Arstasis One Access System, models AAD100 and AAD101, and lot numbers 09I10268, 1OC26337, 09J06281 and 10C12334 distributed between May 14, 2010 and Oct. 13, 2010.