WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and Thoratec due to safety concerns that have been linked to multiple deaths.
According to the FDA, the recall includes both the HeartMate II LVAD and HeartMate 3 LVAD devices, with the main issue being the gradual buildup of biological materials within the devices. This buildup can potentially obstruct the device, leading to decreased effectiveness in pumping blood and triggering alarms indicating low blood flow. The accumulation of biological material typically occurs over two years or more, potentially resulting in serious adverse health consequences, and in some cases, even leading to death.
So far, 14 deaths and 273 injuries have been associated with these obstructions caused by the defective devices. The HeartMate 3 LVAD is the only device of its kind currently approved by the FDA for the treatment of patients with advanced heart failure in the U.S., and it plays a crucial role in delivering blood from the patient’s left ventricle to the rest of the body.
Cardiologists and cardiac surgeons often utilize these devices as a bridge to heart transplantation or as permanent therapy when other treatments are deemed ineffective. The importance of addressing these safety concerns promptly and effectively cannot be overstated, considering the potentially life-threatening consequences associated with the malfunction of these devices.
Patients who have received or are scheduled to receive these affected LVADs are urged to consult with their healthcare providers to determine the best course of action. The FDA’s proactive approach in issuing this recall serves as a reminder of the agency’s commitment to patient safety and underscores the importance of thorough monitoring and evaluation of medical devices to prevent harm and protect public health.