FDA Device recall Z-1948-2020
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique abil…
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique abil… by Cardiac Assist, citing failure to prime due to an assembly error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1948-2020 |
| 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 Kit, Product: 5120-0000 - 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: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961 |
|---|
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-1948-2020%22
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