Vagus Nerve Stimulation — Class II medical device recall Z-0532-2022
Terminated recall by LivaNova USA, Inc., reported 2022-02-09, distributed in AR, IN, KS, MA, MO, NE, WV. A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less
| Recall number | Z-0532-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Inc., Houston, TX, United States |
| Recall initiated | 2021-12-02 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2024-01-25 |
| Distributed | AR, IN, KS, MA, MO, NE, WV |
| Quantity | 10 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05425025750115 |
| Serial numbers | 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458 |
| Model numbers | 303, 303-20, 303-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0532-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.