Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate
II® Left Ventricular Assist System
Thoratec Corporation is initiating a worldwide medical device correction of all
serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or
102139, which have been distributed since the beginning of clinical studies in November 2003. 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.
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