FDA Announces Recall and Product Discontinuation of Boston Scientific LOTUS Edge™ Aortic Valve System
The U.S. Food and Drug Administration (FDA) announced on January 11 a global, voluntary recall of all unused inventory of the Boston Scientific LOTUS Edge™ Aortic Valve System due to "complexities associated with the product delivery system." No safety issues are of concern for patients who currently have an implanted LOTUS Edge valve.
"The voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant," the FDA said. The company plans to halt all related commercial, clinical, research and development and manufacturing activities.
Keywords: ACC Advocacy, Aortic Valve, United States Food and Drug Administration
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