FDA recall Z-1763-2022

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2022-07-21

Report date

2022-10-05

Termination date

2023-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1763-2022