Cardiac Assist, Inc. is recalling two LifeSPARC Pumps because a manufacturing issue may have left epoxy in the device uncured. If the epoxy does not cure properly, it can lead to the sudden and early failure of the pump, which is used to provide circulatory support for patients. These specific units were distributed in Illinois and Florida as part of larger TandemLife LifeSPARC kits.
Uncured epoxy inside the pump mechanism can cause the device to stop functioning prematurely. For patients relying on this pump for life-sustaining blood circulation, a sudden failure could lead to serious injury or death.
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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.
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Sources: FDA iRES · Raw API Response
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