Cardiohelp Emergency Drive, Part No. 70104.8002 recallZ-0986-2019 · Maquet Cardiovascular Us Sales, Llc · initiated Feb 8, 2019
Class I Terminated All recalls posted in March 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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).
Recall details
- Recall number
- Z-0986-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Feb 8, 2019
- Posted by the FDA
- Mar 28, 2019
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 10
- Product code
- DTQ
- FDA submissions
- K102726
- Distribution
- US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
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.
Code information (models, lots, serial numbers)
Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
Other devices under the same FDA submission
1 device cleared under K102726 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA Wall holder HKH 8820Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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