Nearly 14,000 heart pumps tied to hundreds of injuries and more than a dozen deaths are being recalled, according to federal health officials. The HeartMate II and HeartMate 3 Left Ventricular Assist System , produced by Abbott Laboratories' Thoratec Corp., were voluntarily recalled "due to an issue called Extrinsic Outflow Graft Obstruction," the Food and Drug Administration said in a notice.
To date, there have been 273 reported injuries and 14 reports of death associated with this issue. However, the devices haven't been removed from the market. Abbott told FOX Business that earlier this year it communicated to customers about "the potential for biological material to accumulate over time and disrupt the flow of blood through the outflow graft component of LVAD systems.
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