Penumbra Pulls Aneurysm Device Over Deadly Defects

Law360, New York (April 14, 2011, 3:34 PM EDT) -- The U.S. Food and Drug Administration said Wednesday that Penumbra Inc. had recalled more than 260 lots of a device used to treat brain aneurysms over concerns that a defect could cause blood clots and strokes.

The FDA said that in early March, the company began an emergency recall of the Penumbra Coil 400, a thin wire placed into a brain aneurysm, after discovering that the affected lots were prone to detachment.

According to the FDA, the delivery tool used to implant the coil inside the...
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