FDA Device recall Z-1952-2020
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circula…
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circula… by Cardiac Assist, citing failure to prime due to an assembly error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1952-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-06 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardiac Assist |
| Distribution | US |
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.
Reason
Failure to prime due to an assembly error
Identifiers
| code_info | Serial Numbers: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1952-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.