Getinge/Maquet Recalls Cardiohelp Disposable Parts

The FDA alerted healthcare facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump. Patients treated with the HLS Set Advanced should be monitored for the following signs and symptoms and treated accordingly:

• Inflammation, infection, sepsis;
• Localized or systemic inflammatory reaction, fever, stimulation of humoral immune response (SIRS), activation of coagulation and complement cascade, or release of inflammatory molecules (for example cytokines).

Read the FDA safety notice.