Abbott Vascular has recalled the MitraClip Clip Delivery System, due to issue with the Delivery System Deployment Process. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall.

According to the FDA, Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open heart surgery to retrieve the delivery system. Updated instructions and training will be provided for health care providers who use the device.

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. There has been one death.

Read the full FDA recall announcement here.