According to the Congressional report on March 30, the Food and Drug Administration (FDA) in the United States issued a Class I recall, the highest level alert, for a heart pump due to safety risks. More than 66,000 devices have been recalled across the country.
The heart pump is designed to provide short-term support for pumping blood in the ventricles during medical procedures or severe heart attacks. The FDA stated that the pump's catheter may puncture the left ventricular wall during surgery, leading to serious adverse events including left ventricular perforation, free wall rupture, hypertension, inadequate blood supply, and death. The incidents related to this issue have led to 49 deaths and 129 severe injuries.
The Impella heart pump, produced by Abiomed in the United States, has been in use from October 10, 2021, to October 10, 2023, as reported by CCTV journalist Xu Xiao.
(Original Title: U.S. Heart Pump Linked to 49 Deaths Due to Safety Risks; FDA Issues Highest-Level Recall Alert)
