Heater Cooler Unit Usage: The Heater-Cooler Unit — Class II medical device recall Z-0348-2017
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2016-11-09, distributed nationwide. There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a po
| Recall number | Z-0348-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2016-09-27 |
| Classified | 2016-11-02 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2019-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 305 units |
| Reason classes | microbial contamination |
| Model numbers | 70102.8718, 70103.4371HCU, 70103.4653HCU, 704629I, 705501I, 939001I |
Product
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Reason for recall
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
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-0348-2017. 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.