Skip to content
Recall Observatory FDA recall evidence

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.

Z-0986-2019

February 08, 2019

Class I

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 82265
Status
Terminated
Classification
Class I
Quantity
10
Official record key
device-enforcement:Z-0986-2019

Official wording

Reason: 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.

Code information: Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.