# FDA recall Z-0535-2021

> **LivaNova USA Inc** · Class II · device recall initiated 2020-11-12.

## Product

VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.

## Reason for recall

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

## Distribution

International distribution in the countries of Austria and United Kingdom.

## Key facts

- **Recall number:** Z-0535-2021
- **Recalling firm:** LivaNova USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-12
- **Report date:** 2020-12-16
- **Termination date:** 2023-01-12

- **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-0535-2021

## Citation

> AI Analytics. FDA recall Z-0535-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0535-2021. Source: US FDA. Licensed CC0.

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