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HeartMate 3 Left Ventricular Assist System recall labeled as Class I recall

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eMediNexus    23 May 2018

The HeartMate 3™ Left Ventricular Assist System (Abbott) was recalled due to a potential malfunction that may lead to graft occlusion leading to serious adverse events such as blood clots and death. The US FDA has identified this recall as Class I, the most serious type of recall, because of the risk for serious injury or death.

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