GETINGE/MAQUET CARDIOHELP: POTENTIAL INSUFFICIENT PACKAGING STERILITY, FDA RECALL. MARCH 2023.

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In March, 2023, The FDA issued an alert regarding a potential sterility issue in the packaging of the disposable component of the Maquet Cardiohelp system, which includes the oxygenator, heat exchanger, and centrifugal pump. The company identified a gap in packaging validation testing that could compromise sterility.

Being exposed to a medical device that is not sterile can lead to health effects such as inflammation, infection, sepsis, or ischemia. 

Measures were taken to correct this issue, and an informative letter is included in each package. Prior to using the set, a visual examination of the packaging should be conducted to look for signs of stress marks, flaws, or any damage.

We invite you to watch our video with extended information about this issue: 

 

Fig 1. ECMO HLS system, Maquet Getinge Cardiohelp package.

 

Fig 2. ECMO Maquet Getinge Cardiohelp package defect.

Fig 3. ECMO Maquet Getinge Cardiohelp package defect.

 

Source: https://www.fda.gov/medical-devices/letters-health-care-providers/getingemaquet-cardiohelp-system-potential-insufficient-packaging-sterility-hls-set-advanced-letter