The U.S. Food and Drug Administration (FDA) has issued its highest-level alert for the Impella heart pump, a device linked to 49 deaths and 129 injuries. Impella pumps are small devices designed to temporarily support a patient's heart during high-risk surgeries or after severe heart attacks.
Announced on March 21, the FDA's move represents the most serious type of recall, highlighting the device's potential to cause serious injury or death if misused. The alert affects 66,390 Impella devices distributed in the United States over a two-year period starting October 10, 2021.
Approved by the FDA in 2008, the Impella pump operates by threading a catheter with a small hook through the blood vessels into the left ventricle, a crucial chamber of the heart responsible for pumping oxygenated blood throughout the body. While the device provides essential temporary heart assistance, incorrect usage can result in piercing the heart's left ventricle wall, leading to severe health complications such as hypertension, lack of blood flow, and death.
In October 2021, Abiomed, the manufacturer, released a technical bulletin detailing proper usage to prevent heart wall perforations, integrating this information into their doctor training program. However, the FDA noted that Abiomed failed to submit this information to the agency within the required 10-day period. In response, J&J MedTech stated that the company is implementing broad process improvements as part of Abiomed's integration into Johnson & Johnson MedTech's quality systems.
An FDA inspection of Abiomed's U.S. headquarters in Massachusetts in early 2023 uncovered the earlier notification, leading to a warning letter in September. This prompted Abiomed to provide new usage instructions for the heart pump. By late December, the FDA had reviewed and approved updated warnings on the device's label. FDA spokeswoman Audra Harrison emphasized the agency's diligent efforts to mitigate the issue upon its discovery.
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U.S. FDA issues highest alert for a heart pump linked to 49 deaths
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