J&J's Abiomed Heart Pump Faces Multiple Recalls in Short Time

In the summer and fall of 2025, Abiomed, a Johnson & Johnson subsidiary, initiated recalls of multiple versions of its Impella heart pumps due to recurring safety concerns, including incidents associated with patient fatalities. These recalls specifically target the automated Impella controllers, a critical component of the heart pump system utilized in advanced cardiac interventions. The FDA initially announced a recall in July following three patient deaths occurring between 2021 and 2025. According to Medtech Dive, the issue arose from controller malfunctions that failed to recognize the connected pump, potentially leading to inadequate circulatory support for patients. Users were instructed to maintain backup controllers and to replace consoles if a screen malfunctioned.