Abbott Vascular has recalled the MitraClip clip delivery system, following reports of issues with the delivery system deployment process.
The system has malfunctioned in a number of cases, in which the delivery system could not be detached from the clip. In these cases, open heart surgery was necessary to retrieve the delivery system.
According a US Food and Drug Administration recall notice, use of the faulty MitraClip systems could result in patient injury and even death. Currently, nine out of the 3,534 devices on the market have been reported as malfunctioning. One death has been reported.
Abbott Vascular will update their instructions and training for health care providers using the device.
In February 2016, Abbott Vascular instructed physicians to read revised deployment instructions carefully, to train with company representatives and to share this information with other members of staff involved in using the device.
