Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2019 - (Recall #: Z-0986-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: February 8, 2019

Date Posted: April 3, 2019

Recall Number: Z-0986-2019

Event ID: 82265

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.

Status: Terminated

Product Quantity: 10

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.

Voluntary or Mandated:

Voluntary: Firm initiated