Thoratec LLC is recalling approximately 694 HeartMate 3 System Controllers because the user interface membrane or screen may lift at the edges of the housing. This defect can allow fluids to leak into the device and damage the internal circuit boards, which may lead to unexpected alarms, loss of screen visibility, non-functional buttons, or a complete loss of power. If the controller loses power, the heart pump may stop, posing a life-threatening situation for patients relying on the device.
Fluid entering the controller housing can cause internal short circuits, resulting in false alarms or the inability to control the pump. In the most severe cases, the controller may fail to deliver power to the pump, causing it to stop and potentially leading to serious injury or death.
healthcare provider or manufacturer consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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