VNS Therapy Program GMDN: 44077 Model # 3000 V1 — Class II medical device recall Z-0663-2020
Ongoing recall by LivaNova USA Inc, reported 2019-12-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. This recall is being initiated due to reports that that the therapy programming tablet with software version 1
| Recall number | Z-0663-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2018-11-16 |
| Classified | 2019-12-10 |
| Reported by FDA | 2019-12-18 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Quantity | 643 units |
| Reason classes | software |
| Model numbers | 3000, V1.5.2 |
Product
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Reason for recall
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
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-0663-2020. 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.