October 30, 2008 - Thoratec Corp. this week notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having catalog numbers 1355 or 102139), 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, the company said. This may require reoperation to replace the pump, and potentially result in serious injury or death, Thoratec said. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3 percent at 12 months, 6.5 percent at 24 months, and 11.4 percent at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.
For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate