U.S. FDA issues highest alert for a heart pump linked to 49 deaths

The U.S. Food and Drug Administration (FDA) has issued its highest-level alert for a heart pump that has been related to 49 deaths and 129 injuries.

Impella pumps are small devices that temporarily support a patient's heart, such as during high-risk surgeries or after a serious heart attack.

According to a statement posted on the FDA's website on March 21, the move is the "most serious type of recall" since the equipment poses a risk of serious injury or death if used incorrectly.

The notification covers 66,390 devices supplied in the United States over a two-year period beginning on October 10, 2021, according to the government.

The device received FDA approval in 2008. The pump has a catheter with a small hook at the end that is threaded through the blood vessels and into the left ventricle, which is a critical chamber in the heart that pumps oxygenated blood throughout the body.

The left-sided pumps are used to provide temporary heart assistance to patients undergoing high-risk surgeries or recovering from a major heart attack.

However, the regulator warned that if used incorrectly, it might pierce a wall in the heart's left ventricle.

The FDA cautioned that using damaged pumps could result in serious health implications such as "hypertension, lack of blood flow and death."

In October 2021, Abiomed produced a technical bulletin outlining how to use the pump correctly to avoid holes in the heart's wall, which was put into their doctor training program. According to FDA spokeswoman Audra Harrison, the corporation was supposed to submit this information to the agency within 10 days of receiving the notification, but they did not.

When asked why the agency hadn't been notified in 2021, J&J MedTech responded that the business "continue[s] to implement broad process improvements as part of Abiomed's full integration into the Johnson & Johnson MedTech quality systems."

The FDA conducted an inspection of the company's U.S. headquarters in Massachusetts in early 2023, during which investigators discovered the October 2021 notice. The FDA issued a warning letter to Abiomed in September, prompting the company to submit new instructions for using the heart pump.

In late December, the FDA examined and authorized new warnings on the label. "The FDA worked diligently to mitigate this issue after learning about it," Harrison noted in an email.

(Cover image via VCG)