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U.S. Department of Health and Human Services

Class 2 Device Recall TandemHeart Pump

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  Class 2 Device Recall TandemHeart Pump see related information
Date Initiated by Firm March 06, 2020
Create Date May 11, 2020
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-1952-2020
Recall Event ID 85322
510(K)Number K110493  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Code Information Serial Numbers: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967 
Recalling Firm/
Cardiac Assist, Inc
240 Alpha Dr
Pittsburgh PA 15238-2906
For Additional Information Contact SAME
412-963-7770 Ext. 227
Manufacturer Reason
for Recall
Failure to prime due to an assembly error
FDA Determined
Cause 2
Under Investigation by firm
Action LivaNova dba Tandem Life notified consignees via 1st class mail (certified return receipt) on March 06th, 2020, states reason for recall, health risk, and action to take: Check your inventory for the presence of potentially affected TandemHeart pump contained within your ordered kit as per Table 1 provided in Attachment 1; - Ensure any affected kit containing the potentially affected TandemHeart pump still in inventory gets quarantined before they can be returned. 2. Please fill and return Response Form by email to LivaNova.FSCA@livanova.comto confirm appropriate corrective actions have been executed. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used. 3. Potentially affected product still in your inventory will be replaced once the Response Form has been returned to LivaNova. Leverage your TandemLife representativeto aid in the collection of the affected quarantined kit containing the potentially affected TandemHeart pump. Questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.
Quantity in Commerce 46
Distribution US Nationwide distributions.
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 = KFM and Original Applicant = CARDIACASSIST INC.