CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

The Terumo HX2 Temperature Management System provides recalled

Terumo Cardiovascular Systems is recalling The Terumo HX2 Temperature Management System provides temperature control of two. The recall was initiated on 16 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers distributed from 05/02/1985 thru 06/10/2015

Quantity recalled75 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1789-2021
FDA event ID: 87834
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2021
FDA classified: 4 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Heart & Vascular Devices

Timeline

16 Apr 2021	Recall initiated by company
4 Jun 2021	Classified by FDA	+49 days
9 Jun 2021	Published in enforcement report	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

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

Stores named: CVS

Questions about this recall

Is The Terumo HX2 Temperature Management System provides temperature control of two recalled?

Yes. Terumo Cardiovascular Systems recalled The Terumo HX2 Temperature Management System provides temperature control of two on 16 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1789-2021.

Why was it recalled?

Which lots are affected?

All lot numbers distributed from 05/02/1985 thru 06/10/2015

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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