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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiohelp Emergency Drive

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  Class 1 Device Recall Cardiohelp Emergency Drive see related information
Date Initiated by Firm February 08, 2019
Date Posted March 28, 2019
Recall Status1 Terminated 3 on May 14, 2020
Recall Number Z-0986-2019
Recall Event ID 82265
510(K)Number K102726  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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.
Code Information Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Ms. Karen LeFevere
973-709-7000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = MAQUET CARDIOPULMONARY AG
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