The U.S. Food and Drug Administration (FDA) has made a startling announcement, designating Abiomed’s recall of blood pumps as the most serious, citing potential for grave harm or even death. The recalled devices, known as Impella Left Sided Blood Pumps, play a crucial role in providing short-term support to pumping chambers during high-risk heart procedures.
According to the FDA, Abiomed is recalling specific models of these pumps due to a hazardous flaw that could result in the puncturing of the left ventricle wall of the heart during operations. The repercussions of such an error have been dire, with the agency noting 129 reported cases of serious injuries, including a staggering 49 instances resulting in death attributed to their use.
While Abiomed markets other pumps under the Impella brand for various therapeutic purposes, the focus now rests on addressing the critical issue at hand to ensure patient safety and prevent further tragic outcomes.
