FDA Issues Safety Notice For MitraClip Delivery System

The U.S. Food and Drug Administration (FDA) has issued a safety notice for Abbott’s MitraClip Delivery System regarding proper operation and deployment of the device. The company has received some reports of unsuccessful separation of the MitraClip from the delivery system during implantation, prompting the safety notice.

According to the FDA, Abbott is “requiring training of all MitraClip implanting physicians … to ensure continued safe use of the device.” Read the FDA announcement

Clinical Topics: Cardiac Surgery, Valvular Heart Disease, Cardiac Surgery and VHD, Mitral Regurgitation

Keywords: Comorbidity, Mitral Valve, Mitral Valve Insufficiency, Prostheses and Implants, Surgical Instruments, United States Food and Drug Administration

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