Abbott/Thoratec Corp. recalls HeartMate II and HeartMate 3 left ventricular assist system (LVAS) due to long-term buildup causing an obstruction.
Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called Extrinsic Outflow Graft Obstruction, (EOGO)
This happens when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery.
This buildup can obstruct the device, making it less effective in helping the heart pump blood. It can trigger alarms indicating low blood flow and affect the device's ability to help the heart properly. The accumulation of biological material typically occurs over two years or more.
The use of affected LVAS may cause serious adverse health consequences and in worst cases, could result in death. There have been 273 reported injuries and 14 reports of death associated with this issue.
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