# FDA recall Z-1389-2020

> **LivaNova USA Inc.** · Class III · device recall initiated 2019-07-03.

## Product

LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.

## Reason for recall

Perfusion tubing pack was packaged with the incorrect cuvette.

## Distribution

US Nationwide distribution in the state of IL.

## Key facts

- **Recall number:** Z-1389-2020
- **Recalling firm:** LivaNova USA Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-03
- **Report date:** 2020-03-04
- **Termination date:** 2021-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arvada, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2020

## Citation

> AI Analytics. FDA recall Z-1389-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1389-2020. Source: US FDA. Licensed CC0.

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