# FDA recall Z-1763-2022

> **Cardiac Assist, Inc** · Class I · device recall initiated 2022-07-21.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1763-2022
- **Recalling firm:** Cardiac Assist, Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-21
- **Report date:** 2022-10-05
- **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-1763-2022

## Citation

> AI Analytics. FDA recall Z-1763-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1763-2022. Source: US FDA. Licensed CC0.

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