Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System
MedSun: Newsletter #31, December 2008

FDA Press Release

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. For more information, please read the Press Release available under Additional Information below.

You may read a recent MedSun report with this device in the clinical environment online available under Additional Information below. This report is also featured in this month's Highlighted Reports.

Additional Information:

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System. FDA Press Release. October 24, 2008.
http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112525.htm


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