FDA Alerts Archive

Certitude Delivery System by Edwards Lifesciences: Class I Recall – Mold Overflow Defect Which May Obstruct Blood Flow

January 11, 2018 Print this page Audience: Risk Manager, Cardiology, Surgery Model/Item Numbers: 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A, 9600SDS20A, 9600SDS23A, 9600SDS26A, 9600SDS29A ISSUE: Edwards LifeSciences is recalling its Certitude Delivery System due to a molding overflow defect in the button …