# FDA recall Z-1099-2019

> **LivaNova USA Inc.** · Class II · device recall initiated 2018-09-14.

## Product

SORIN Heater-Cooler System 3T, REF 16-02-85    Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

## Reason for recall

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

## Distribution

US Distribution to states of: IN, MO, and OH.

## Key facts

- **Recall number:** Z-1099-2019
- **Recalling firm:** LivaNova USA Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-14
- **Report date:** 2019-04-17
- **Termination date:** 2022-09-14

- **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-1099-2019

## Citation

> AI Analytics. FDA recall Z-1099-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1099-2019. Source: US FDA. Licensed CC0.

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