The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling the instructions for use for its Impella Left Sided Blood Pumps due to risk that the pump catheter may perforate the wall of the left ventricle in the heart.

According to the agency, “use of the affected Impella pumps may cause serious adverse health consequences, including left ventricular perforation or free wall rupture, hypertension, lack of blood flow, and death.” The FDA has classified this as a Class I recall, the most serious type of recall.

For more information, access the FDA website.