Recall Z-1763-2022 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Cardiac Assist, Inc
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
| Date | Sep 23, 2022 (initiated Jul 21, 2022) |
| Status | Terminated |
| Reason | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. |
| Root cause | Under Investigation by 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. |
| Quantity | 723 units (484 currently in field) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183623 | LifeSPARC Pump, LifeSPARC Controller Cardiacassist, Inc., Jul 9, 2019 |