"FDA Issues Highest Alert for Heart Pump Linked to 49 Deaths: What You Need to Know"

In a recent development, the US Food and Drug Administration (FDA) has issued its highest-level alert regarding a heart pump linked to 49 deaths and 129 injuries. The Impella left-sided pumps, manufactured by Abiomed, are used to provide temporary support to a patient's heart during high-risk procedures or after a severe heart attack. However, the FDA has warned that incorrect usage of the pump could result in puncturing the wall of the heart's left ventricle.

The FDA classified this alert as the "most serious type of recall" due to the potential risk of serious injuries or death if the device is not used properly. While the device will remain on the market, Abiomed has issued new instructions for the pump to address the safety concerns. This recall affects 66,390 devices distributed in the US over a two-year period.

It is important for healthcare professionals and patients to be aware of the risks associated with these heart pumps and to follow the updated instructions provided by the manufacturer. The FDA's inspection of Abiomed's office revealed a failure to disclose the risk of heart perforation during insertion of the pumps, leading to a warning letter and the issuance of an "Urgent Medical Device Correction letter" with revised instructions.

For more information on this alert and what you need to know about the Impella heart pump, watch our video and stay informed about your health and safety. Remember to always consult with your healthcare provider for any concerns or questions related to medical devices.

Stay safe and take care of your heart health!
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