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Cardiac Assist, Inc recalls TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-000
Recalled October 5, 2022 · FDA recall Z-1763-2022 · Cardiac Assist
Hazard
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. · FDA Class I
Units
723 units (484 currently in field)
Sold at
US Nationwide distribution.
Description
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Product
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Manufacturer(s)
Cardiac Assist, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →