# FDA recall Z-0869-2020

> **LivaNova USA Inc** · Class II · device recall initiated 2018-11-16.

## Product

Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1.  The firm  name on the label is CYBERONICS, INC., Houston, TX.  Vagus nerve stimulator.

## Reason for recall

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators.  *Note this recall occurred in November 2018.

## Distribution

Distribution US nationwide, including Puerto Rico.  There was no foreign/military/government consignees.

## Key facts

- **Recall number:** Z-0869-2020
- **Recalling firm:** LivaNova USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-11-16
- **Report date:** 2020-02-05
- **Termination date:** 2022-12-12

- **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-0869-2020

## Citation

> MORVS. FDA recall Z-0869-2020. Retrieved 2026-10-30 from https://api.morvs.ai/recall/Z-0869-2020. Source: US FDA. Licensed CC0.

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