Z-1116-2015Class II

Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that...

Name: Z-1116-2015 Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2015-02-06
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-02-06 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood... on 2015-02-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1116-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-06
Posted: 2015-02-13
Terminated: 2016-10-17
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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 code: DWC Controller, Temperature, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/6/2015, URGENT MEDICAL DEVICE RECALL notifications were mailed to the affected hospitals. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call customer service at 1-800-521-2818.
Quantity in commerce: 103 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1116-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1116-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-13

Product code DWC

K071521Class IITerumo Hx2 Temperature Management SystemTerumo Cardiovascular Systems Corp. / cleared 2007-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)