| Subject: | Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System |
| Category: | Food and Drug Administration (FDA)
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| Published: | Mon, 27 Oct 2008 - 08:00 am |
| Thoratec Corporation has initiated 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 to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries since the beginning of clinical studies in November 2003. According to Thoratec, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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