TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
- Company
- Cardiac Assist, Inc
- Recall Initiated
- March 6, 2020
- Terminated
- November 20, 2020
- Recall Number
- Z-1950-2020
- Quantity
- 15
- Firm Location
- Pittsburgh, PA
Reason for Recall
Failure to prime due to an assembly error
Distribution
US Nationwide distributions.
Lot / Code Info
Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972
Root Cause
Under Investigation by firm
Action Taken
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.