---
title: "Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model ... — FDA record Z-0532-2022 | Is It on Recall"
description: "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 beco"
url: https://isitonrecall.com/recall/fda-device-z-0532-2022-vagus-nerve-stimulation-vns-therapy-leads-perenniadura-model-303-model-303-20-pereniadura-lead-2-0-m/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrod... — FDA record Z-0532-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 2, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class II
- **Recalling firm**: LivaNova USA, Inc.
- **Quantity**: 10
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0532-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0532-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## Dates in the source

- **Report date**: Feb 9, 2022
- **Recall initiation date**: Dec 2, 2021
- **Center classification date**: Jan 28, 2022
- **Termination date**: Jan 25, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0532-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [LivaNova USA, Inc. records](https://isitonrecall.com/brand/livanova-usa-inc/)