FDA issues alert on heart pump linked to 49 deaths
By Vicky Wong
The US Food and Drug Administration (FDA) has issued its highest-level alert about a heart pump that has been linked to 49 deaths and 129 injuries.
The Impella left sided pumps are used to temporarily support a patient’s heart during high-risk procedures or after a severe heart attack.
But the regulator warned it could puncture a wall in the heart’s left ventricle if used incorrectly.
The device’s manufacturer, Abiomed, has issued new instructions for the pump.
A summary posted on the FDA’s website on 21 March classified the move as “most serious type of recall” because of the risk of serious injuries or death if the device is used incorrectly.
The agency warned that the use of affected pumps may also cause serious adverse health consequences, including “hypertension, lack of blood flow, and death”.
But it added that the recall was a correction, not a product removal, and the device will remain on the market.
The notice relates to 66,390 devices that were distributed in the US over two years starting from 10 October 2021, the agency said.
