TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
FDA Recall Z-1763-2022 · Posted 2022-09-23
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Recalling FirmCardiac Assist, Inc
Recall StatusTerminated
Product CodeDWA
Date Initiated2022-07-21
Date Terminated2023-08-08
Product Quantity723 units (484 currently in field)
Reason for Recall
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Firm Action
On July 21, 2022, the recalling firm notified impacted customers through mailed letters. Customers were instructed to use Operations Manual revision 15 and to discard all previous revisions of the Operations Manuals.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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