FDA warns healthcare providers against using Getinge/Maquet cardiovascular devices due to ongoing safety and quality concerns.

The FDA warns healthcare providers against using certain Getinge/Maquet cardiovascular devices, such as the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps, due to ongoing safety and quality concerns. Getinge has taken corrective measures, but the FDA continues to receive reports related to device issues. Healthcare providers are advised to transition away from these devices if possible, and follow specific recommendations when using them. Getinge has issued 12 voluntary recalls for the Cardiosave IABP and 8 for the Cardiohelp system and HLS set.

May 08, 2024
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