FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: 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.
- Recall number
- Z-0986-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-02-08
- Posted
- 2019-03-28
- Terminated
- 2020-05-14
- 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.
- 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
- 10
- Distribution
- US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
- Lot, serial or model codes
- Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
- 510(k) numbers
- ["K102726"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28