SORIN Heater-Cooler System 3T — Class II medical device recall Z-1099-2019
Terminated recall by LivaNova USA Inc., reported 2019-04-17, distributed in IN, MO, OH. For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
| Recall number | Z-1099-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc., Arvada, CO, United States |
| Recall initiated | 2018-09-14 |
| Classified | 2019-04-05 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2022-09-14 |
| Distributed | IN, MO, OH |
| Quantity | 6 devices |
| Serial numbers | 16S11877, 16S13187, 16S14887, 16S15335, 16S15336, 16S15337 |
| Model numbers | 16-02-85 |
Product
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Reason for recall
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
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-1099-2019. 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.