The Terumo HX2 Temperature Management System provides temperature… — Class II medical device recall Z-1789-2021
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2021-06-09. Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectat
| Recall number | Z-1789-2021 |
|---|---|
| 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 | 2021-04-16 |
| Classified | 2021-06-04 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-11-29 |
| Countries outside the US | AE, AU, BE, CA, CH, CL, CN, CO, DE, DO, ES, FR, GB, GR, HK, ID, IL, IN, IR, IT, JP, KR, MX, MY, NL, NO, NZ, PH, RU, SA, SE, SG, TH, TR, TW, VN |
| Quantity | 75 devices |
| Model numbers | 809810, HX2 |
Product
The 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. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Device Name / Model Number: HX2 Temperature Management System (P/N 809810) Catalog Number: 809810
Reason for recall
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
Machine access
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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.