The U.S. Food and Drug Administration (FDA) has issued its highest alert regarding a heart pump that has been linked to 49 deaths and 129 injuries.
Left-sided Impella pumps are used to temporarily support a patient’s heart during high-risk procedures or after a serious heart attack.
But the regulator warned it could pierce a wall of the left ventricle of the heart if used incorrectly.
The device’s manufacturer, Abiomed, has released new instructions for the pump.
A summary posted on the FDA’s website on March 21 classifies the move as “the most serious type of recall” because of the risk of serious injury or even death if the device is used incorrectly.
The agency warned that use of the affected pumps could also have serious adverse health consequences, including “high blood pressure, lack of blood flow and death.”
But he added that the recall was a correction, not a product withdrawal, and that the device would remain on the market.
The notice affects 66,390 devices distributed in the United States over two years beginning October 10, 2021, the agency said.
The device received FDA approval in 2008.
The pump is fitted with a catheter with a small hook on the end, which is threaded through the blood vessels and up to the left ventricle – a key chamber in the ear used to pump oxygen-filled blood throughout the body.
A spokesperson for Johnson & Johnson – which acquired Abiomed in 2022 – told Reuters: “This notification does not constitute a withdrawal of the device and Impella heart pumps remain on the market and available to patients. »
Abiomed first disclosed the risk of heart perforation when inserting the pumps in a technical bulletin issued in October 2021, but did not share that information with the FDA at the time, the agency said.
The agency carried out an inspection of the company’s offices in Massachusetts in early 2023 and sent a warning letter to Abiomed in September in which it criticized – among other things – the lack of information from the FDA on the risk of cardiac perforation.
The warning letter led Abiomed to issue an “urgent medical device correction letter” late last year, containing revised instructions for properly using the heart pump, including how to position the pump catheter or use imaging when rotating during procedures, the FDA said.
News Source : www.bbc.com
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