medical Class I Updated 2019-04-03

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

Distribution: Nationwide (United States)
Lot/Code Info: Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
View official government recall

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