FDA: Abbott issues safety notice for MitraClip Delivery System
Editor's Note
The Food and Drug Administration on February 29 announced a safety notice issued by Abbott (Abbott Park, Illinois) to reinforce the proper procedures used to operate and deploy its MitraClip Delivery System.
The company has received nine reports of device malfunction where the user was unable to separate the implantable clip from the delivery system.
MitraClip is used to perform percutaneous transcatheter mitral valve repair.
Posted 02/29/2016] AUDIENCE: Cardiology, Risk Manager, Surgery ISSUE: Abbott 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.
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