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

Recall Insight

This FDA Devices action (record #Z-1763-2022) was formally reported on October 5, 2022, with the manufacturer initiating the action on July 21, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Cardiac Assist, Inc is listed as the recalling firm, operating out of Pittsburgh, PA. Federal records indicate 723 units (484 currently in field) units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.