LivaNova SMART PERFUSION PACK INSPIRE 8S — Class III medical device recall Z-1389-2020
Terminated recall by LivaNova USA Inc., reported 2020-03-04, distributed nationwide. Perfusion tubing pack was packaged with the incorrect cuvette.
| Recall number | Z-1389-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc., Arvada, CO, United States |
| Recall initiated | 2019-07-03 |
| Classified | 2020-02-27 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2021-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 27 packages |
| UPC / GTIN / UDI-DI | 00803622140136 |
| Lot numbers | 1912100141 |
| Model numbers | 046008200 |
Product
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Reason for recall
Perfusion tubing pack was packaged with the incorrect cuvette.
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-1389-2020. 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.