Z-0986-2019Class I

Cardiohelp Emergency Drive, Part No. 70104.8002

Name: Z-0986-2019 Cardiohelp Emergency Drive, Part No. 70104.8002
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2019-02-08
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2019-02-08 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the... on 2019-02-08. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0986-2019
Classification: Class I
Status: Terminated
Initiated: 2019-02-08
Posted: 2019-03-28
Terminated: 2020-05-14
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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).
Quantity in commerce: 10
Distribution: US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Product codes and lots: Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0986-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28

Product code DTQ

K102726Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2011-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)