HeartWare is recalling its Ventricular Assist Device (HVAD) with serial numbers lower than HW25838. A design problem with the driveline connector can cause fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
The recall includes 105 units distributed nationwide. The HVAD is designed for use both in and out of hospital settings, including during patient transport. HeartWare Inc. sent an “Urgent Medical Device Recall Letter” to affected customers with instructions.