Events

Recall of Device Recall Terumo HX2 Temperature Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70492
  • Event Risk Class
    Class 2
  • Event Number
    Z-1116-2015
  • Event Initiated Date
    2015-02-06
  • Event Date Posted
    2015-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133894
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Reason
    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.
  • 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.

Device

Device Recall Terumo HX2 Temperature Management System
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA