Maquet Cardiovascular Us Sales, Llc recalls Cardiohelp Emergency Drive, Part No. 70104.8002 Product U
Recalled Product
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Hazard / Issue
Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
Issued by
FDA
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