# FDA recall Z-0926-2023

> **Cardiac Assist, Inc** · Class I · device recall initiated 2022-12-05.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0926-2023
- **Recalling firm:** Cardiac Assist, Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-12-05
- **Report date:** 2023-01-25
- **Termination date:** 2023-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2023

## Citation

> AI Analytics. FDA recall Z-0926-2023. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0926-2023. Source: US FDA. Licensed CC0.

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