A device used to treat brain aneurysms is being recalled because a defect in the product may lead to serious injury including blood clots and stroke.

A brain aneurysm, also known as a cerebral aneurysm, is a weakness in the wall of a cerebral artery or vein that causes a localized dilation or ballooning of the blood vessel. Aneurysms may result from congenital defects, or from preexisting conditions such as high blood pressure, the buildup of fatty deposits in the arteries, or from head trauma.

Brain aneurysms require emergency treatment and are generally treated with hypotensive therapy, surgical clipping, or endovascular coiling.

The Penumbra Coil 400, manufactured by Penubra Inc., is used during endovascular coiling. It is a small platinum coil placed in to a brain aneurysm through the blood vessels leading to the brain. Once the deice is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.

Penumbra has notified their customers and distributors of the recall, and the company states that all affected units distributed both inside and outside the United States have been accounted for and returned to the company.

The recall is listed as a Class 1, the most serious type of recall issued by the Food and Drug Administration, and is reserved for products in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.