Thoratec Recalls the HeartMate II
On October 24, 2008, Thoratec issued a world-wide recall of the Heartmate II Left Ventricular Assist System (LVAS) with catalogue numbers 1355 and 102139. These systems have ben distributed since the beginning of clinical studies starting in November 2003. According to the FDA Recall information:
Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.
Anyone who has is currently supported by the HeartMate II LVAS should contact their doctor immediately so that the percutaneous lead can be assessed for wear and fatigue. There has been 27 confirmed cases where the system needed to be replaced. Five deaths have resulted in patients who were unable to receive a pump replacement.
If you or a loved one has been injured by from this defective product, contact us immediately to find out your legal rights.
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