# FDA recall Z-1791-2021

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

## Product

The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature.   The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia.    Device Name / Model Number:  TCM II, with Cardioplegia, 110V/60Hz (P/N 164925)  TCM II, without Cardioplegia, 110V/60Hz (P/N 164930)  TCM II, with Cardioplegia, 220V/50Hz (P/N 164935)  TCM II, without Cardioplegia, 220V/50Hz (P/N 164940)  TCM (P/N 15747)    Catalog Number: 4415, 164925, 164930, 164935, 15747

## 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-1791-2021
- **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-1791-2021

## Citation

> AI Analytics. FDA recall Z-1791-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1791-2021. Source: US FDA. Licensed CC0.

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