# FDA recall Z-1789-2021

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2021-04-16.

## 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.

## Distribution

Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam

## Key facts

- **Recall number:** Z-1789-2021
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-16
- **Report date:** 2021-06-09
- **Termination date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1789-2021

## Citation

> AI Analytics. FDA recall Z-1789-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1789-2021. Source: US FDA. Licensed CC0.

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