On January 20, 2023, the FDA added information for health care providers and patients about Medtronic’s January 2023 communication requesting the return of 12 batteries that have electronic properties that may indicate they have a battery weld defect. Medtronic first communicated about this weld defect in May, 2022 and expanded the communication to all HVAD battery users in June, 2022. Additional information can be found on the Recalls Related to HVAD System web page.
On June 3, 2021, Medtronic stopped the sale and distribution of the HeartWare Ventricular Assist Device (HVAD) system given the increased risk of mortality and neurological adverse events in patients using the device, and a malfunction where the device may fail to restart. Both problems may lead to serious injuries or death.
The FDA continues to work with Medtronic to ensure the health and safety of device users, which remains our highest priority. This includes ensuring Medtronic continues to meet its obligations to support patients and health care providers.
The FDA is committed to providing important updates about the HeartWare device and we will continue to inform the public as new information becomes available.
Information about the HVAD System
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Heart failure is a chronic condition that typically worsens over time and can result in end-stage heart failure and death. Patients with end-stage heart failure suffer debilitating shortness of breath, physical exhaustion, painful swelling in legs and feet, and fluid buildup in the lungs and abdomen.
The Medtronic HVAD System helps the heart by supporting the weak left ventricle and providing additional blood flow. The Medtronic HVAD System is a ventricular assist device used in end-stage heart failure patients who are waiting for a heart transplant. This use is known as bridge-to-transplant. The Medtronic HVAD System may also be used in end-stage heart failure patients who cannot have a heart transplant, and whose symptoms cannot be managed by medications. This use is known as destination therapy, which can extend a patient's life and improve their quality of life.
The Medtronic HVAD System includes a pump implanted in the space around the heart (pericardium), a controller that controls the speed and function of the pump, a tube inserted into the heart to drain the blood, and a tube inserted in the aorta for the blood that is being pumped. The controller remains outside the patient's body and is connected to the pump by a flexible tube that passes through the patient's skin. The controller is powered either by batteries or a power supply that can be connected to a standard electrical power outlet.
As discussed in the Agency's benefit-risk assessments in 2012 and 2017, and for patients currently supported on the device, the probable benefits of the HVAD System outweigh the probable risks. The benefits of the HVAD system include survival on the device, ability to place the HVAD pump without requiring an abdominal pocket, and ability to place the device in smaller patients when compared to the alternatives. The probable risks include stroke and other neurological events, major infection, bleeding, and right heart failure, all of which could lead to death. The FDA recognizes neurological events, in particular strokes, associated with the HVAD System as the most important probable risk. The current labeling for the HVAD System for patients and health care providers conveys these benefits and risks.