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.
This recall has been terminated (originally issued March 28, 2019).
- Recall Initiated
- February 8, 2019
- Posted
- March 28, 2019
- Terminated
- May 14, 2020
- Recall Number
- Z-0986-2019
- Quantity
- 10
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Lot / Code Info
Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
Root Cause
Process control
Action Taken
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).