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Maquet Cardiovascular Us Sales, Llc recalls Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies
Recalled April 3, 2019 · FDA recall Z-0986-2019 · Maquet Cardiovascular Us Sales
Hazard
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. · FDA Class I
Units
10
Sold at
US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Description
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.
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.
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →