FDA Recalls Penumbra, Inc. Coil 400 Used for Brain Aneurysms
BioScience Technology --- The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.