Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil
MedSun: Newsletter #60, May 2011

FDA MedWatch Safety Alert

The pull wire on the coil 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.

Additional Information:

FDA Medical Device Safety. Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall. April 13, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251402.htm