![FDA Warns About Widely Used Heart Pumps Linked to Deaths and Serious Injuries](https://img.theepochtimes.com/assets/uploads/2023/12/20/id5550236-shutterstock_1960356370.jpg)
The U.S. Food and Drug Administration issued a warning for commonly used heart pumps that may cause damage to the heart. The pump’s function is to reduce the workload on the heart’s ventricles, allowing the heart to recover. However, the FDA has noted potential serious health consequences associated with the pump itself. These issues include perforation of the left ventricle wall, free wall rupture, hypertension, decreased blood flow, and even death. Since 2021, over 66,000 devices have been recalled in the U.S. alone. In June 2023, the company recalled certain Impella RP Flex pumps due to reports of higher-than-expected rates of blood clots. Previous investigations For instance, in December 2020, a patient’s pump stopped for five minutes and could not be restarted because the purge side arm of the pump broke. Abiomed did not report this malfunction to the FDA within the 30-day requirement based on the company’s awareness of the issue.