Maquet Cardiovascular Us Sales, Llc recalls Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to…

Recall date

February 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0986-2019

FDA classification

Class I

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.