Getinge recalls ECMO machines due to emergency drive issue

Medical device maker Getinge is recalling 41 of its Cardiohelp Emergency Drive life support machines due to the risk of the device's emergency drive becoming stuck when clinicians attempt to activate the function. The FDA has classified it as a Class 1 recall, the most serious type. 

Getinge first initiated the recall in October, according to the FDA's recall notice published Dec. 8. Two models were affected that had been distributed between Sept. 14, 2022, and July 27, 2023. Overall, 41 U.S. devices were affected. 

Getinge issued the recall because the devices — which are used to oxygenate and remove carbon dioxide from blood to support the heart and lungs for up to six hours — have been found to be at risk of blockages or other issues preventing the emergency drive function from being turned on properly. 

"The stiff hand crank is caused by a scrounger disc that interferes with the turning of the crank," the FDA's recall notice said. "If the emergency drive is needed, a clinician may not be able to turn the handle to drive the pump or may not be able to turn the handle as fast as is needed to adequately support the patient. If this occurs, the patient will lose adequate hemodynamic support or gas exchange; the results of which could include ischemia, hypoxia, stroke, or death."

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