Abbott Issues Voluntary Safety Notice on MitraClip Delivery System Deployment Process

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Abbott Issues Voluntary Safety Notice on MitraClip Delivery System Deployment Process

02/28/2016 10:21 AM EST

Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). Abbott has received nine Medical Device Reports of malfunction.

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