| Subject: | FDA Issues Update for Class 1 Recall: Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 27 Jul 2007 - 12:00 pm |
| The FDA has issued an update to the June 8, 2007 Class I recall for the Thoratec® TLC-II® Portable Ventricular Assist Device (VAD) Driver, Catalog Number 20010-0000-032. From September 1, 2005 through June 4, 2007, Thoratec® distributed 378 VAD units to 378 hospitals (251 within the U.S and 127 outside the U.S.).The product was recalled because the VAD support for the patient's circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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