Terumo HX2 Temperature Management System provides temperature control… — Class II medical device recall Z-1116-2015
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2015-02-25, distributed nationwide. Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and sho
| Recall number | Z-1116-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2015-02-06 |
| Classified | 2015-02-13 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2016-10-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 103 units |
| Reason classes | device malfunction |
| Serial numbers | 0001, 00016, 0002, 1001, 1002, 1042, 1116, HX2, PT0003, PT0004 |
| Model numbers | 809810, 809810TK, 812231, 812240 |
Product
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
Reason for recall
Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
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-1116-2015. 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.