HeartMate Devices Linked to Injuries and Deaths Receive FDA Recall

MIAMI, FL – The Food and Drug Administration has issued its most serious recall for two heart devices due to their connection to numerous injuries and deaths. The HeartMate 2 and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, have been linked to at least 14 deaths and over 4,500 reports of potential harm. These mechanical heart pumps are crucial for patients with end-stage heart failure who are awaiting a transplant or …

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FDA Recalls Abbott and Thoratec HeartMate LVADs Due to Safety Concerns

Washington, D.C. – The U.S. Food and Drug Administration (FDA) has issued a Class I recall alerting the public about the safety risks associated with Abbott and Thoratec’s HeartMate left ventricular assist devices (LVADs). Nearly 14,000 devices are being recalled due to concerns over the gradual buildup of biological materials within the devices, which can lead to serious health complications and, in some cases, fatal outcomes. The FDA’s announcement follows reports of 14 deaths and …

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