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 (LVAS/LVAD), produced by Abbott Laboratories’ Thoratec Corp., were voluntarily recalled “due to an issue called Extrinsic Outflow Graft Obstruction,” the Food and Drug Administration (FDA) said in a notice.
The FDA said the devices work by taking over the pumping function of the left ventricle, the main pumping chamber of the heart. They divert blood from the weakened left ventricle and propel it into the body’s main artery, the aorta, helping to circulate blood throughout the body. They are used inside and outside the hospital, according to health officials.
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Officials discovered that biological material can build up between certain components, including those added during surgery, which can “obstruct the device, making it less effective in helping the heart pump blood,” according to the recall notice.
Build up typically occurs over a two-year period or longer. This build up can “trigger alarms indicating low blood flow and affect the device’s ability to help the heart properly,” the notice said.
The FDA identified this as a Class I recall, the most serious type of recall, because the devices may cause serious injuries or death.
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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.
The FDA told FOX Business that the agency is working with the company “to ensure they fully investigate the reported deaths and adverse events associated with this recall to determine if further correction is needed.”
“We take seriously our role to provide timely and accurate information to the public and will keep health care providers and the public informed if new information becomes available, including significant new recommendations or FDA actions related to these devices,” the FDA said.
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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The company said that “while rates of outflow obstruction are low, Abbott worked to ensure physicians were aware of persistent low flow alarms that can provide an early warning to the potential issue as well as about diagnostic recommendations that can assess any potential obstruction.”
Abbott said it also reinforced options for treating an outflow obstruction.