On May 8, 2024, the FDA warned healthcare providers about ongoing safety concerns with Getinge/Maquet cardiovascular devices, specifically the Cardiosave Hybrid and Rescue IABP devices and the Cardiohelp system with HLS Sets. Despite corrective actions, these devices pose significant risks. The FDA advises transitioning to alternatives and reporting adverse events. Multiple recalls and serious injury reports have highlighted persistent issues with these devices, leading to enhanced FDA oversight.