FDA has issued a Class I recall on the Boston Scientific Innova™ Self-Expanding Stent System. A total of 72 products are affected and the manufacturer, Boston Scientific Corporation, is conducting a recall of these products.
The Innova™ Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions. The manufacturer has received 6 complaints involving no deployment or partial deployment of the Innova Stents. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and 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.
According to the local supplier, the affected products are not distributed in Hong Kong.
For details, please refer to the FDA link: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm270461.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.