LivaNova Heater-Cooler System 3T — Class II medical device recall Z-1498-2020
Terminated recall by LivaNova USA Inc., reported 2020-03-25, distributed nationwide. The firm is providing validated cleaning and disinfection instructions in their revised operating instructions
| Recall number | Z-1498-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc., Arvada, CO, United States |
| Recall initiated | 2020-02-24 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2022-08-04 |
| Distributed | Nationwide (US) |
Product
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Reason for recall
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
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-1498-2020. 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.