FDA: HeartWare VAD splice kit recalled

Editor's Note

The Food and Drug Administration (FDA) on May 5 announced that Medtronic is recalling its splice kit used to repair the driveline of the HeartWare Ventricular Assist Device (VAD).

The kit was recalled because of a design problem that prevents the repaired cable assembly from withstanding excessive force or pull, which could damage the cable assembly and interrupt the electrical connection.

An interruption in the electrical connection may cause the pump to stop, which could lead to serious adverse consequences, including patient death.

The company issued the kits between April 2010 and March 2015.

Posted 05/05/2017] AUDIENCE: Cardiology, Risk Manager, Transplantation, Nursing, Patient ISSUE: Medtronic is recalling the driveline splice kit due to a design problem that would prevent the repaired cable assembly from withstanding excessive force or pull (e.g. accidental dropping of controllers or snagging driveline cables).