Stop using now Medical device recall · FDA · Published April 16, 2021

Terumo Sarns TCM II Blood Heat Exchanger Recall: Discontinue Use Due to Cleaning Protocol

Terumo recalls Sarns TCM II blood heat exchangers due to inability to validate cleaning protocols. Affected units must be discontinued and disposed of to prevent potential safety risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1791-2021Medical device Terumo ›

Stop using this now

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.

Take action

Contact the company

Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586

✎ GovInfoNow plain-language explainer

Terumo is recalling Sarns TCM II blood heat exchangers because they cannot validate a cleaning protocol that meets regulatory standards. Users must stop using and dispose of these devices to avoid potential safety risks. Read more at govinfonow.com/recall/62772-terumo-sarns-tcm-ii-blood-heat-exchanger-recall-discontinue-use.

Source Summary by GovInfoNow · govinfonow.com/recall/62772-terumo-sarns-tcm-ii-blood-heat-exchanger-recall-discontinue-use · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1791-2021

Cite this page

“Terumo Sarns TCM II Blood Heat Exchanger Recall: Discontinue Use Due to Cleaning Protocol.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62772-terumo-sarns-tcm-ii-blood-heat-exchanger-recall-discontinue-use. Based on FDA recall #Z-1791-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1791-2021%22&limit=1).

The Food and Drug Administration announced on April 16, 2021, that Terumo Cardiovascular Systems Corporation is recalling The Sarns TCM II devices. The agency stated the recall is necessary because the company could not validate a cleaning protocol to meet regulatory standards.

How to tell if you have it

Brand: Terumo
Product: The Sarns TCM II (system)
Model Numbers: 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 Numbers: 4415, 164925, 164930, 164935, 15747
Lot Codes: All lot numbers distributed from 05/02/1985 thru 06/10/2015

The hazard

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, the company determined that users should discontinue use of and dispose of HX2, TCM I and TCM II devices.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since 2017-06-27. Other recent recalls include the Terumo CDI OneView BPM Probe Recall (2025-05-28), the Terumo CDI OneView Hematocrit Probe recall (2025-03-03), and the Terumo Cardiovascular Procedure Kits recall (2024-02-20). Other recent recalls of similar products include Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk (2026-07-17), Covidien Mon-a-Therm Temperature Probe Recall: Lack of FDA Clearance (2026-04-23), and Glypto Cryo Machine Recall: Lack of 510(k) Clearance (2026-08-24).

How to tell if you have this one

Check for the model numbers TCM II with or without Cardioplegia, 110V/60Hz or 220V/50Hz, and catalog numbers 4415, 164925, 164930, 164935, or 15747. Units distributed from May 2, 1985, through June 10, 2015, are affected.

Brand
Terumo
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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

Recall number	Product, codes & lots	Quantity
Z-1789-2021	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; All lot numbers distributed from 05/02/1985 thru 06/10/2015	75 devices
Z-1790-2021	The Sarns Temperature Control and Monitor unit (TCM) 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. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940; All lot numbers distributed from 05/02/1985 thru 06/10/2015	1176 devices
Z-1791-2021	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; All lot numbers distributed from 05/02/1985 thru 06/10/2015	995 devices

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately discontinue use and dispose of all affected Sarns TCM II blood heat exchangers.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Apr 16, 2021Firm started the recall
Jun 4, 2021FDA classified it Class II
Jun 9, 2021Published in FDA’s Enforcement Report
Nov 29, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62772-terumo-sarns-tcm-ii-blood-heat-exchanger-recall-discontinue-use">Terumo Sarns TCM II Blood Heat Exchanger Recall: Discontinue Use Due to Cleaning Protocol (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1791-2021 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1791-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.