FDA issues highest-level alert for heart pumps connected to 49 reported deaths ...Middle East

The Food and Drug Administration (FDA) has issued a Class I recall, the highest-level alert, for heart pumps that have been linked to nearly 50 deaths. Impella heart pumps are used for short term support of pumping blood in the chambers of the heart’s ventricles during medical procedures or after a severe heart attack. The Impella Left Sided Blood Pumps are affected because the “pump catheter may perforate (cut) the wall of the left ventricle in the heart.” The FDA has warned of the risk and the company has advised customers to review new instructions. “During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impellla pumps

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