TANDEM LIFE LivaNova LIFESPARC Controller — Class I medical device recall Z-1763-2022
Terminated recall by Cardiac Assist, Inc, reported 2022-10-05, distributed nationwide. Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not disp
| Recall number | Z-1763-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Assist, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2022-07-21 |
| Classified | 2022-09-23 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00814112020562, 00814112020623 |
| Serial numbers | C00006, C00015, C00016, C00023, C00034, C00035, C00038, C00039, C00040, C00041, C00042, C00043, C00044, C00045, C00046, C00048, C00049, C00050, C00051, C00052, C00053, C00054, C00055, C00056, C00057 and 475 more |
| Model numbers | 5900-0000, 5900-0001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1763-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.