FDA Device recall Z-1763-2022

TANDEM LIFE LivaNova LIFESPARC Controller

FDA Device
Class I
terminated
Published 2022-10-05

On 2022-10-05 the FDA classified a Class I recall of TANDEM LIFE LivaNova LIFESPARC Controller by Cardiac Assist, citing critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1763-2022
Classification	Class I
Status	terminated
Initiated	2022-07-21
Published	2022-10-05
Last updated	2026-09-13 11:56 UTC
Company	Cardiac Assist
Distribution	US

Product

TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

Reason

Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

Identifiers

code_info	Model 5900-0000 - UDI-DI: 00814112020562 Model 5900-0001 - UDI-DI: 00814112020623 Serial No.: C00115, C50232, C50253,… Model 5900-0000 - UDI-DI: 00814112020562 Model 5900-0001 - UDI-DI: 00814112020623 Serial No.: C00115, C50232, C50253, C50403, C00195, C50619, C50623, C50161, C50167, C50388, C50432, C50505, C00189, C50437, C50671, C50690, C50362, C50648, C00048, C00087, C00149, C50274, C50506, C50308, C50319, C00040, C00107, C50160, C50016, C50604, C50493, C50355, C00126, C00155, C50113, C00041, C00135, C00042, C00035, C50012, C50019, C00176, C50386, C00052, C00076, C00092, C50490, C00095, C50149, C00182, C50392, C50337, C50451, C50306, C50460, C50512, C50082, C50092, C50174, C00151, C50328, C50349, C50111, C50501, C00157, C50363, C50353, C50476, C50212, C50219, C50350, C00174, C00006, C50076, C50105, C50235, C50613, C50197, C50375, C50463, C50517, C50632, C50662, C00199, C00205, C50699, C50269, C50398, C50618, C50645, C50100, C50101, C50626, C50204, C50266, C50330, C50031, C50050, C50241, C50524, C50181, C50365, C00038, C50237, C00190, C50598, C50005, C50213, C50214, C50283, C00143, C50287, C50288, C

code_info

Model 5900-0000 - UDI-DI: 00814112020562 Model 5900-0001 - UDI-DI: 00814112020623 Serial No.: C00115, C50232, C50253,…

Model 5900-0000 - UDI-DI: 00814112020562 Model 5900-0001 - UDI-DI: 00814112020623 Serial No.: C00115, C50232, C50253, C50403, C00195, C50619, C50623, C50161, C50167, C50388, C50432, C50505, C00189, C50437, C50671, C50690, C50362, C50648, C00048, C00087, C00149, C50274, C50506, C50308, C50319, C00040, C00107, C50160, C50016, C50604, C50493, C50355, C00126, C00155, C50113, C00041, C00135, C00042, C00035, C50012, C50019, C00176, C50386, C00052, C00076, C00092, C50490, C00095, C50149, C00182, C50392, C50337, C50451, C50306, C50460, C50512, C50082, C50092, C50174, C00151, C50328, C50349, C50111, C50501, C00157, C50363, C50353, C50476, C50212, C50219, C50350, C00174, C00006, C50076, C50105, C50235, C50613, C50197, C50375, C50463, C50517, C50632, C50662, C00199, C00205, C50699, C50269, C50398, C50618, C50645, C50100, C50101, C50626, C50204, C50266, C50330, C50031, C50050, C50241, C50524, C50181, C50365, C00038, C50237, C00190, C50598, C50005, C50213, C50214, C50283, C00143, C50287, C50288, C

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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
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
TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory s…
FDA Device · Class II · 2020-05-20 · Cardiac Assist

All Cardiac Assist recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1763-2022%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.