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A new warning is being issued over a heart pump whose use could perforate the heart. The device has already been linked to over 100 injuries and 49 deaths. These left-sided Impella heart pumps are made by Abiomed, a subsidiary of Johnson & Johnson MedTech. Abiomed posted the new warning on the devices on the U.S. Food and Drug Administration’s website. “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the statement said, although it adds that “this recall is a correction, not a product removal.” The advisory informs those implanting the Impella devices about revised instructions for use, including “carefully position the pump catheter during operative procedures.” These Impella pumps resemble a long straw inserted into the heart. They are used during high-risk cardiac procedures (for example, during certain types of heart attack), to help maintain proper blood flow from the heart to the body. The pump is threaded through major heart vessels and into the heart’s left ventricle, the organ’s main pumping chamber. “Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate [cut] the wall of the left ventricle in the heart,” the company warned in its statement. “During operations, the Impella device could cut through the wall of the… read on > read on >