# FDA recall Z-1118-2020

> **LivaNova USA Inc** · Class II · device recall initiated 2019-08-13.

## Product

VNS Therapy SENTIVA  Generator Model # 1000    Labeling  26-0009-6800 Model 1000 Generator Sample Labels  26-0009-9600 Patient s Manual for Depression  26-0009-9500 Patient s Manual for Epilepsy  76-0000-5000 VNS Therapy System Physician s Manual  (refer to Attachment 1)

## Reason for recall

Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

## Distribution

US:  FL, GA, KS, MO, and UT.    No OUS distribution

## Key facts

- **Recall number:** Z-1118-2020
- **Recalling firm:** LivaNova USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-13
- **Report date:** 2020-02-19
- **Termination date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2020

## Citation

> AI Analytics. FDA recall Z-1118-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1118-2020. Source: US FDA. Licensed CC0.

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