The US Food and Drug Administration (FDA) has issued a top-level warning 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 serious heart attack.

But the regulator warned that if used incorrectly it could puncture a wall in the left ventricle of the heart.

The device manufacturer, Abiomed, has issued new instructions for the pump.

A summary posted on the FDA’s website on March 21 classified the action as the “most serious form of recall” due to the risk of serious injury or death if the device is misused.

The agency warned that use of the affected pumps could also cause serious adverse health effects, including “hypertension, lack of blood flow and death.”

But it added that the recall was a correction, not a product removal, and that the device will remain on the market.

The notice covers 66,390 devices distributed in the US over two years from October 10, 2021, the agency said.

The device received FDA approval in 2008.

The pump has a catheter with a small hook on the end, which is passed through the blood vessels to the left ventricle – a key chamber in the heart that is used to pump oxygen-packed blood around 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 to patients.”

Abiomed first disclosed the risk of heart perforation during pump insertion in a technical bulletin posted in October 2021, but did not share this information with the FDA at the time, the agency said.

The agency conducted an inspection of the company’s Massachusetts office in early 2023 and sent a warning letter to Abiomed in September, criticizing, among other things, its failure to inform the FDA about the risk of heart perforation.

The warning letter resulted in the Abiomed issuing an ‘Urgent Correction Letter for Medical Devices’ late last year, with revised instructions on how to properly use the heart pump, including how to position the pump’s catheter or use imaging when rotating of it during procedures, the FDA said.

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