Boston, Massachusetts – The US Food and Drug Administration (FDA) has issued a critical warning regarding a heart pump manufactured by Abiomed, linking it to 49 deaths and 129 injuries. The Impella left sided pumps are commonly used to provide temporary support to a patient’s heart during high-risk procedures or following a severe heart attack. However, the FDA has cautioned that improper use of the device may result in puncturing the heart’s left ventricle wall, leading to serious injuries or death.
In response to the FDA’s alert, Abiomed has released updated instructions for the pump to mitigate the risk of complications. The FDA classified this recall as the most serious type due to the potential for severe injuries or fatalities resulting from incorrect usage of the affected pumps. Complications associated with the use of these pumps include hypertension, compromised blood flow, and even death.
Although the recall is categorized as a correction rather than a product removal, the FDA emphasized the necessity for healthcare providers to adhere to the new instructions to ensure patient safety. Approximately 66,390 devices distributed in the US over a two-year period are impacted by this alert, with the device receiving FDA approval back in 2008.
The pump features a catheter with a small hook that is threaded through blood vessels into the left ventricle, a crucial chamber responsible for pumping oxygenated blood throughout the body. Following the acquisition of Abiomed by Johnson & Johnson in 2022, a spokesperson confirmed that the Impella heart pumps will continue to remain on the market to serve patients in need.
Notably, Abiomed initially disclosed the risk of heart perforation during pump insertion in a technical bulletin released in October 2021. However, the company failed to inform the FDA of this risk at the time. As a result, the FDA conducted an inspection at Abiomed’s Massachusetts office in early 2023, leading to a warning letter issued to the company in September highlighting the lack of communication regarding the risk of heart perforation.
Subsequently, Abiomed issued an “Urgent Medical Device Correction letter” containing revised instructions on the proper use of the heart pump. These instructions include guidance on catheter positioning and the utilization of imaging during procedures to mitigate the risk of heart perforation. As the FDA continues to monitor the situation, healthcare providers are urged to exercise caution and follow the updated guidelines to ensure patient safety when using the Impella left sided pumps.