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.
FDA MedWatch Safety Alert. Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy. June 17, 2011.