Institute of Good Manufacturing Practices India®

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Abbott recalls the Heartmate LVAD communication system

Abbott issued a recall for a communication system that monitors heart failure patients implanted with its Heartmate 3 left ventricular assist device (LVAD) because of the risk of unexpectedly causing the heart pump to stop or start. The Food and Drug Administration (FDA) announced this recall, stating potential serious health consequences such as lightheadedness, changes in blood flow, loss of consciousness, and even death. Although eight patient injuries were reported, there were no fatalities. The FDA classified this event as a Class I recall, emphasizing that the correction does not require product removal. Acquired in 2017 from St. Jude Medical, Abbott's Heartmate device offers mechanical circulatory support for end-stage heart failure patients, often serving as a bridge to heart transplant. With Medtronic withdrawing its competing pump from the market, the FDA advised healthcare providers to switch to Abbott's Heartmate 3 LVAD. However, the use of Abbott's device also poses risks, including death, bleeding, respiratory and heart failure, stroke, and device malfunctions. Abbott is recalling version 1.0.32 of the Heartmate Touch communication system, which interfaces with a controller to display a patient's cardiovascular status during LVAD procedures or close monitoring situations in hospitals. The recall impacts 1,560 devices distributed in the U.S. between May 7, 2020, and Dec. 18, 2023.