# FDA recall Z-0532-2022

> **LivaNova USA, Inc.** · Class II · device recall initiated 2021-12-02.

## Product

Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303.   Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)

## Reason for recall

A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

## Distribution

US: NE, MO, AR, WV, KS, MA, IN

## Key facts

- **Recall number:** Z-0532-2022
- **Recalling firm:** LivaNova USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-02
- **Report date:** 2022-02-09
- **Termination date:** 2024-01-25

- **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-0532-2022

## Citation

> AI Analytics. FDA recall Z-0532-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0532-2022. Source: US FDA. Licensed CC0.

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