Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart.
This recall (a correction and not a product removal) affects a number of Impella pumps in the U.S. That includes Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAsist and Impella LD.
Impella pumps provide short-term support for the ventricles during high-risk catheter-based percutaneous coronary interventions (PCIs). Uses also include for ongoing cardiogenic shock, open-heart surgery or cardiomyopathy. The therapy aims to reduce the work of the heart’s ventricles and support the circulatory system.
Abiomed recalled the left-sided blood pumps in this…