VNS Therapy Programming System — Class II medical device recall Z-2572-2018
Terminated recall by LivaNova USA Inc, reported 2018-08-08, distributed in AZ, CA, GA, IA, IL, IN, MO, MT…. Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
| Recall number | Z-2572-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2018-01-24 |
| Classified | 2018-07-28 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2023-11-29 |
| Distributed | AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI |
| Quantity | 243 devices |
| Serial numbers | 0011, 11R57F2, 1G7G1F2, 1HT77F2, 1JR57F2, 1MYB7F2, 1TQ57F2, 1YR77F2, 2CP57F2, 2DR77F2, 2DT77F2, 2LYB7F2, 4GR57F2, 4GT77F2, 4JS77F2, 4LR77F2, 55T77F2, 57P57F2, 5D0C7F2, 5HS77F2, 5KS77F2, 5MR77F2, 5NQ57F2, 5RQ57F2, 5VQ57F2 and 217 more |
| Model numbers | 10-0011-0500, 3000, V1.0.2.2 |
Product
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Reason for recall
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
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-2572-2018. 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.