Cardiac Assist, Inc TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Brand
Cardiac Assist, Inc
Lot Codes / Batch Numbers
Serial Numbers: 00142681 00142683 00142949 00142950 00142951
Products Sold
Serial Numbers: 00142681 00142683 00142949 00142950 00142951
Cardiac Assist, Inc is recalling TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Us due to Failure to prime due to an assembly error. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to prime due to an assembly error
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026