Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers

Update: May 8, 2024 

Today, the FDA issued a Letter to Health to Care Providers to alert health care providers and facilities about continued safety and quality concerns with the Getinge cardiovascular medical devices, including the Cardiohelp System.

The FDA recommends that health care providers transition away from these devices and seek alternatives, if possible. If health care providers continue to use the devices, we recommend that you follow the recommendations below.

March 1, 2023

The U.S. Food and Drug Administration (FDA) is alerting health care 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.

On February 13, 2023, Getinge/Maquet issued an Urgent Medical Device Correction to inform users about potential problems with packaging sterility for the HLS Set Advanced products. 

The FDA is not aware of reports of adverse events due to this issue to date. 

The FDA is issuing this letter to ensure you are aware of the manufacturer's recall notice and the recommended actions.

Recommendations

The FDA recommends that health care facilities and providers who use the Getinge/Maquet Cardiohelp system:

• Review the recall notice from Getinge/Maquet for all HLS Set Advanced products. 
  • Be aware that all available and newly produced HLS Set Advanced are affected by this recall. 
  • Should you need to purchase the HLS Set Advanced, you will continue to receive product affected by this recall.
• Consider using an alternative device to the Getinge/Maquet Cardiohelp system with HLS Set Advanced.
• If you do not have an alternative device available for use:
  • Before using the HLS Set Advanced, perform a visual inspection of the primary packaging, and check for stress marks, defects, or damage to the packaging. 
    • Do not use the HLS Set Advanced if you see stress marks, defects, or damage to the packaging. 
    • Be aware that the packaging defects might be difficult to see with only your eyes. 
    • As a precautionary measure, consider identifying experts in your facility, such as sterile processing staff, to assist with inspecting the HLS Set Advanced packaging using advanced visualization methods. 
  • Monitor patients treated with the HLS Set Advanced for the following signs and symptoms and treat 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). 
• Contact Getinge/Maquet if you have any questions or did not receive the recall notice, at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. EST.
• Report any adverse events or suspected adverse events, such as infections potentially related to the affected products, with HLS Set Advanced to the FDA.

Background

The Getinge/Maquet Cardiohelp system is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for either circulatory support, pulmonary support, or both, for up to six hours. 

The Cardiohelp system together with the HLS Set Advanced is intended to be used in hospitals and outside the hospital environment, such as hospital transport, for up to six hours.

The HLS Set Advanced is a disposable part of the Cardiohelp system that contains the oxygenator, heat exchanger, and integrated centrifugal pump.

FDA Actions

The FDA is working with Getinge/Maquet to ensure the necessary packaging validation testing for HLS Set Advanced is completed and the issue is resolved.

The FDA will continue to monitor for reports of adverse events related to the issue.

The FDA will keep health care providers and the public informed if new or additional information becomes available.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any medical device. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.

• Health care personnel employed by facilities that are subject to the FDA's User Facility Reporting Requirements should follow the reporting procedures established by their facilities.
• Voluntary reports can be submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).