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Abbott is recalling the HeartMate 3 LVAS by updating the instructions for use after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the titanium apical cuff. In all reported events, the issue was observed during implantation of the device.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these affected devices may cause serious injuries, serious health consequences, or death. Please be aware, this recall is a correction, not a product removal.
Questions?
Customers with questions should contact their local Abbott representative or call 612-346-3514.
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