FDA Recalls MitraClip Clip Delivery System
The U.S. Food and Drug Administration (FDA) has issued a recall for Abbott Vascular’s MitraClip Clip Delivery System after reports of issues in detaching the delivery system from the clip. In these cases, the delivery system was retrieved through open heart surgery.
According to the FDA, the “use of affected products may cause serious adverse health consequences, including serious patient injury or death. Currently there are 3,534 devices on the market, with nine reports of this malfunction.” Updated instructions and training for health care professionals will be released from Abbott Vascular following the recall.
Keywords: Prostheses and Implants, Surgical Instruments, United States Food and Drug Administration, Cardiac Surgical Procedures, Angiography
< Back to Listings