Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy
MedSun: Newsletter #62, July 2011

FDA MedWatch Safety Alert

Complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted as the issue occurs during delivery of the stent.

Additional Information:

FDA MedWatch Safety Alert. Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy. June 17, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259764.htm


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