Simplifying Global Compliance
FDAnews Device Daily Bulletin
Detachment Issues Lead to Recall for Heart System
April 10, 2012
The FDA has issued a Class 1 recall
for Thoratec’s HeartMate II left ventricular assist system due to possible detachment of the bend relief from its intended position around the proximal outflow graft which may allow the graft to kink or deform, resulting in reduction of blood flow.
Copyright ©2017. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing