Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2012 - (Recall #: Z-0278-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

Product Classification:

Class II

Date Initiated: October 16, 2012

Date Posted: November 21, 2012

Recall Number: Z-0278-2013

Event ID: 63344

Reason for Recall:

Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up

Status: Terminated

Product Quantity: 19 units

Code Information:

Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.

Distribution Pattern:

Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI

Voluntary or Mandated:

Voluntary: Firm initiated