FDA recall Z-0986-2019

Maquet Cardiovascular Us Sales, Llc · Class I · device

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.

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-02-08
Report date
2019-04-03
Termination date
2020-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2019