FDA Device recall Z-1953-2020
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal cir…
- 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 - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal cir… by Cardiac Assist, citing failure to prime due to an assembly error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1953-2020 |
| 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 - DL31 RD, Product: 5720-3631 - 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: 00142676 00142677 00142678 00142679 00142680 00142910 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Cardiac Assist
- LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000
FDA Device · Class II · 2023-09-06 · Cardiac Assist - SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
FDA Device · Class I · 2023-01-25 · Cardiac Assist - TANDEM LIFE LivaNova LIFESPARC Controller
FDA Device · Class I · 2022-10-05 · Cardiac Assist - SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass
FDA Device · Class III · 2021-12-08 · Cardiac Assist - Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization
FDA Device · Class II · 2021-05-05 · Cardiac Assist
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1953-2020%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.