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.
FDA Recall Z-0986-2019 · Posted 2019-03-28
Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDTQ
Date Initiated2019-02-08
Date Terminated2020-05-14
Product Quantity10
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.
Firm Action
Maquet has issued an Urgent Medical Device Recall dated February 26, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that their Emergency Drives had already been inspected and replaced with a loaner Emergency Drive if found to be affected. Affected E-Drives were returned to Getinge for servicing. Upon servicing, a service technician will return the Emergency Drive to your facility.
Customers were asked to complete and sign the customer response form to acknowledge receipt of the notification.
If you have any questions, please contact your Maquet Cardiopulmonary (MCP)/Getinge representative or call the Maquet Cardiopulmonary (MCP)/Getinge Customer Support at +1 (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.