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Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Discussion in 'FDA Recalls' started by Food and Drug, May 31, 2018.

  1. Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

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