Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HX2" Temperature Management Systems Recalled by Terumo Cardiovascular Systems Corporation Due to Terumo Cardiovascular Systems (Terumo CVS) is conducting a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.
Affected Products
HX2" Temperature Management Systems; 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. Product Usage: HX2 Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Quantity: 6412 units
Why Was This Recalled?
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report