Washington, D.C. – The U.S. Food and Drug Administration (FDA) issued a Class I recall on nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and Thoratec, citing safety concerns that have led to multiple deaths. The recall includes both the HeartMate II LVAD and HeartMate 3 LVAD due to the gradual buildup of biological materials within the devices, which can hamper their effectiveness in assisting the heart to pump blood.
According to an advisory released by the FDA, the accumulation of biological material in the devices can trigger alarms indicating low blood flow and impact their ability to function properly. This buildup typically occurs over a period of two years or more and can have serious adverse health consequences, potentially resulting in death. So far, 14 deaths and 273 injuries have been associated with these obstructions.
The HeartMate 3 LVAD, approved by the FDA for the treatment of patients with advanced heart failure, is currently the only device of its kind available in the U.S. for this patient population. Cardiologists and cardiac surgeons often rely on these devices before or after a heart transplant. In some cases, the HeartMate 3 LVAD is used as a permanent destination therapy when other options are not viable.
The FDA’s action underscores the importance of addressing safety concerns in medical devices to prevent harm to patients. The recall of these HeartMate LVADs serves as a reminder of the critical role regulatory agencies play in safeguarding public health. Health care providers are urged to discontinue the use of the affected devices and take necessary steps to ensure patient safety.
As investigations continue into the safety issues related to these LVADs, patients and healthcare professionals are advised to stay informed of any updates from the FDA. The FDA is working closely with Abbott and Thoratec to address the concerns raised by the recall and prevent further harm to patients relying on these devices for life-saving treatment. It is crucial for all stakeholders to prioritize patient safety and take prompt action to mitigate any risks associated with medical devices.