Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

The device manufacturer Abiomed has issued a recall, issued Class I by the FDA, for its left-sided heart pumps due to cases in which the pump catheter has perforated the left ventricle wall. In its letter, Abiomed advised clinicians to carefully position the pump catheter, use imaging to aid in positioning, and to use caution in high-risk patients. It also specified that the recall is a correction, not a total product removal.