FDA Medical Device Recalls (openFDA)
Cardiac Assist, Inc: 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.
- Recall number
- Z-1952-2020
- Recalling firm
- Cardiac Assist, Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-03-06
- Posted
- not on file
- Terminated
- 2020-11-20
- Reason
- Failure to prime due to an assembly error
- Root cause
- 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
- 46
- Distribution
- US Nationwide distributions.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K110493"]
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 3002228812
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28