FDA Issues High-Level Alert for Impella Left-Sided Heart Pumps

The FDA has issued a high-level alert regarding the Impella left-sided heart pumps, which have been associated with 49 deaths and 129 injuries. Despite the recall, the device will remain available on the market. Abiomed, the manufacturer of the device, has released new instructions for the pump in response to the FDA’s alert. The FDA’s notice pertains to 66,390 devices distributed in the US over a two-year period starting from October 10, 2021. This development underscores the importance of adhering to proper usage guidelines for medical devices, particularly those designed to support critical bodily functions.