The US Food and Drug Administration (FDA) has issued a high-level alert on a heart pump that has been related to 49 deaths and 129 injuries. The Impella left-sided pumps are used to provide temporary heart assistance to patients undergoing high-risk surgeries or recovering from a major heart attack. However, the regulator warned that, if used incorrectly, it might pierce a wall in the left ventricle of the heart. Abiomed, the device’s manufacturer, has revised the pump’s instructions.
The FDA cautioned that using damaged Abiomed heart pumps could result in serious health implications
According to a statement posted on the FDA’s website on March 21, the move is the “most serious type of recall” since the equipment poses a risk of serious injury or death if used incorrectly.
The FDA cautioned that using damaged pumps could result in serious health implications such as “hypertension, lack of blood flow, and death”. However, it clarified that the recall was a correction, not a product removal, and that the device will remain on the market.
The notification covers 66,390 devices supplied in the United States over a two-year period beginning on October 10, 2021, according to the government. The device received FDA approval in 2008. The pump has a catheter with a small hook at the end that is threaded through the blood vessels and into the left ventricle, which is a critical chamber in the heart that pumps oxygenated blood throughout the body.
A spokesperson for Johnson & Johnson – which acquired Abiomed in 2022 – told Reuters: “This notification is not a device removal, and Impella heart pumps remain on the market and available for patients.”
Abiomed originally revealed the risk of heart perforation during pump implantation in a technical bulletin published in October 2021 but did not notify the FDA at the time, according to the regulator.
The government conducted an investigation of the firm’s Massachusetts location in early 2023 and sent a warning letter to Abiomed in September, criticizing, among other things, a failure to notify the FDA of the danger of heart perforation.
The warning letter prompted Abiomed to issue a “Urgent Medical Device Correction letter” late last year, which included revised instructions for correctly using the heart pump, such as how to position the pump’s catheter or use imaging when turning it during procedures, according to the FDA.