FDA Issues Highest-Level Alert for Heart Pump Linked to 49 Deaths
NEW YORK — In a bold move, the US Food and Drug Administration (FDA) has sounded the alarm on a heart pump associated with 49 fatalities and 129 injuries.
The Impella left-sided pumps, designed to provide temporary support to a patient’s heart during risky procedures or following a severe heart attack, have been identified as potential hazards by the regulator.
If used incorrectly, the pump could potentially puncture a wall in the heart’s left ventricle, posing grave risks to patients. The device’s manufacturer, Abiomed, has responded by issuing new instructions for the pump.
A summary released on the FDA’s website on March 21 labeled this action as the “most serious type of recall”, emphasizing the significant threat of severe injuries or even death if the device is mishandled.
The FDA cautioned that utilization of the affected pumps could lead to serious adverse health outcomes, such as hypertension, compromised blood flow, and potential fatalities. However, it clarified that the recall was a corrective measure, not a complete product removal, and that the device would still be available on the market.
The alert pertains to a total of 66,390 devices distributed in the US over a two-year period beginning on Oct. 10, 2021. The device received FDA approval back in 2008.
The pump features a catheter with a small hook at the end, which is threaded through the blood vessels into the left ventricle—a crucial heart chamber responsible for pumping oxygen-rich blood throughout the body.
A spokesperson for Johnson & Johnson, the parent company that acquired Abiomed in 2022, reassured Reuters that “this notification is not a device removal, and Impella heart pumps will continue to be available for patients.”
Abiomed initially disclosed the risk of heart perforation during pump insertion in a technical bulletin released in October 2021, but failed to inform the FDA at that time, according to the agency.
Following an inspection of the company’s Massachusetts office in early 2023, the FDA issued a warning letter to Abiomed in September, citing the company’s failure to update the FDA on the risk of heart perforation among other concerns.
This warning prompted Abiomed to issue an “Urgent Medical Device Correction Letter” towards the end of last year, containing revised instructions for the proper use of the heart pump, including guidance on catheter positioning and the use of imaging during procedures, as stated by the FDA. — BBC
