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 left ventricle if used incorrectly.
The device’s manufacturer, Abiomed, has issued new instructions for the pump, the BBC reports.
A summary posted on the FDA's website classified the move as “most serious type of recall” because of the risk of serious injuries or death if the device is used incorrectly.
However, it added that the recall was a correction, not a product removal, and the device would remain on the market.
The notice relates to 66 390 devices distributed in the US over two years starting from 10 October 2021.
The device was given FDA approval in 2008.
Abiomed first disclosed the risk of heart perforation during insertion of the pumps in a technical bulletin posted in October 2021, but did not share this information with the FDA at the time.
The agency carried out an inspection in early 2023, and sent a warning letter to Abiomed in September where it criticised – among other things – a failure to update the FDA on the risk of heart perforation.
The warning letter resulted in Abiomed issuing an “Urgent Medical Device Correction letter” late least year, containing revised instructions for using the heart pump correctly, including how to position the catheter or use imaging when turning it during procedures.
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