FDA Device recall Z-1950-2020
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal…
- 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: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal… by Cardiac Assist, citing failure to prime due to an assembly error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1950-2020 |
| 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: 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.
Reason
Failure to prime due to an assembly error
Identifiers
| code_info | Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 0014293…Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972 |
|---|
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-1950-2020%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.