IMPORTANT SAFETY INFORMATION

HeartWare HVAD System

URGENT PRODUCT UPDATE

Medtronic has stopped the distribution and sale of the HVAD™ System as of June 3, 2021, and has notified physicians to cease new implants of the Medtronic HVAD™ System and transition to an alternative commercial LVAD for all future implants. Prophylactic explant of the HVAD™ System is not recommended at this time.

INDICATIONS FOR USE

The HeartWare™ HVAD™ System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

WARNINGS AND PRECAUTIONS

Proper use and upkeep of the HeartWare™ HVAD™ System is important to keep the pump working well. This device may cause serious and life threatening events, including stroke. Managing your blood pressure may reduce the risk of stroke. Never remove both power sources at the same time (batteries or power adapters) since this will stop the pump, which could lead to serious injury or death. At least one power source must be connected at all times. Always keep a spare controller and fully charged spare batteries available at all times in case of an emergency. Do not disconnect the driveline from the controller or the pump will stop. Avoid kinking or twisting your driveline. Avoid devices and conditions that may induce strong static discharges as this may cause the VAD to fail to work normally or stop. Magnetic resonance imaging (MRI) should not be used, as it could cause severe harm to you and the pump.

POTENTIAL COMPLICATIONS

Implantation of a VAD requires major surgery. There are many known risks associated with the surgical procedure as well as after the HVAD has been implanted. These risks include, but are not limited to, death, stroke, device malfunction, blood clots, bleeding, other types of heart failure, infection, red blood cell destruction, and total body infection.

See the HeartWare HVAD System Patient Manual for detailed information regarding instructions on operating the HeartWare HVAD System and on necessary medical care. If you have any questions after reading the manual, please ask your clinician.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.