# FDA recall Z-1498-2020

> **LivaNova USA Inc.** · Class II · device recall initiated 2020-02-24.

## Product

LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

## Reason for recall

The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

## Distribution

U.S. Nationwide distribution including Puerto Rico.    This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected.    O.U.S. - none

## Key facts

- **Recall number:** Z-1498-2020
- **Recalling firm:** LivaNova USA Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-24
- **Report date:** 2020-03-25
- **Termination date:** 2022-08-04

- **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-1498-2020

## Citation

> AI Analytics. FDA recall Z-1498-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1498-2020. Source: US FDA. Licensed CC0.

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