—#187214

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

FDA product code: DWC — Controller, Temperature, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071521
Affected lot / code info: All lot numbers distributed from 05/02/1985 thru 06/10/2015

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On 04/30/2021, Terumo issued an Urgent Medical Device Removal notice to customer via letter notifying users to discontinue the use of and dispose of HX2, TCM I and TCM II devices. Customers were instructed to confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. For questions contact Terumo CVS Customer Service: 1-800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2021-04-16
Terminated: 2023-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.