SHIP KIT — Class I medical device recall Z-0926-2023
Terminated recall by Cardiac Assist, Inc, reported 2023-01-25, distributed nationwide. A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the
| Recall number | Z-0926-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Assist, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2022-12-05 |
| Classified | 2023-01-19 |
| Reported by FDA | 2023-01-25 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 763 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00814112020562, 00814112020623 |
| Serial numbers | C00006, C00015, C00016, C00023, C00031, C00034, C00035, C00037, C00038, C00039, C00040, C00041, C00042, C00043, C00044, C00045, C00048, C00049, C00050, C00051, C00052, C00053, C00054, C00055, C00057 and 475 more |
| Model numbers | 5900-0000, 5900-0001 |
Product
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Reason for recall
A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, 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-0926-2023. 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.