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Information for HeartMate II, Thoratec Corp.

Product group Active implantable medical devices
Reference 01208/08

Urgent field safety notice to users of implantable heart assist pumps HeartMate II LVAS of Thoratec Corporation, Pleasanton, CA, USA, due to possible risk of separation of the silicone bend relief from the metal connector of the percutaneous lead that connects the pump to the system controller.

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