TANDEM LIFE LivaNova LIFESPARC Controller recalled over injury risk

Recall date

July 21, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cardiac Assist, Inc recalls TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001.…

Recall number

Z-1763-2022

FDA classification

Class I

Brand / firm

Cardiac Assist, Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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