Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2015 - (Recall #: Z-1116-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 6, 2015

Date Posted: February 25, 2015

Recall Number: Z-1116-2015

Event ID: 70492

Reason for Recall:

Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.

Status: Terminated

Product Quantity: 103 units

Code Information:

HX2 Temperature Management System, 120V Catalog # 809810 serial numbers: 00016, 0001 1116 HX2 Temperature Management System, 100V Catalog # 812231 serial numbers: 0001, 1002, PT0003, PT0004 HX2 Temperature Management System, 240V Catalog # 812240 serial numbers: 0001, 0002 HX2 Temperature Management System, Trial Kit Catalog # 809810TK serial numbers: 1001 1042

Distribution Pattern:

US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated