FDA issues alert on heart pump associated with 49 deaths

By Bernard Turk On Mar 30, 2024

The Food and Drug Administration issued its highest-level alert this month about a heart pump associated with reports of 49 deaths and dozens of serious injuries, sharing updated instructions from the device’s maker to doctors on how they should use the device.

The Impella pumps are tiny devices used temporarily to help support a patient’s heart, such as during high-risk procedures or after a severe heart attack. If the pump is used incorrectly, it could cut the wall of the heart’s left ventricle, a key cardiac chamber that helps pump blood full of oxygen to the body.

Abiomed, the device’s manufacturer, is issuing new instructions to physicians on use of the pump, including how to carefully position the pump’s catheter or use imaging when turning it during procedures.

On March 21, the FDA posted a summary on its website detailing the changes and classified the move as the “most serious type of recall” because of the risk of serious injuries or death if the device is used incorrectly. Even though the FDA referred to a recall, the device will remain on the market. The New York Times first reported details of the Impella pump.

Abiomed did not immediately return a request for comment Friday.

Johnson & Johnson MedTech acquired Abiomed in 2022. In a statement, J&J MedTech called cuts to the left ventricle a “rare and known complication during invasive cardiology procedures” and highlighted actions taken to try to reduce the risk.

“A commitment to quality, patient safety, and reliability is the basis for everything we do,” the company wrote in an email.

The FDA first cleared the pump for use in 2008, and the device is aimed at letting the heart rest by helping take over the pumping function of the heart. The agency is working with Abiomed to investigate reports of 49 deaths associated with the pump, but the FDA said it is not yet known whether the deaths can be attributed directly to the pump. It may be difficult to confirm a direct cause and effect between the device and the injuries.

In October 2021, Abiomed published a technical bulletin providing guidance on how to use the pump correctly to better avoid perforations to the heart’s wall and incorporated this into its training for doctors. According to FDA spokeswoman Audra Harrison, the company should have submitted this information to the agency within 10 days of the notice, but didn’t do so.

Asked why the agency hadn’t been alerted in 2021, J&J MedTech said the company “continue[s] to implement broad process improvements as part of Abiomed’s full integration into the Johnson & Johnson MedTech quality systems.”

Early last year, the FDA completed an inspection of the company’s U.S. headquarters in Massachusetts, and agency officials found the October 2021 bulletin. That prompted the FDA to send a warning letter to Abiomed in September, which resulted in the company submitting revised instructions for using the heart pump.

The FDA reviewed and approved updated warnings in a label change in late December. “The FDA worked diligently to mitigate this issue after learning about it,” Harrison wrote in an email.

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