Events

Recall of Device Recall Terumo APS 1

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
    44851
  • Event Risk Class
    Class 2
  • Event Number
    Z-0204-2009
  • Event Initiated Date
    2008-07-18
  • Event Date Posted
    2008-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64437
  • 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
    Cardiopulmonary bypass heart-lung machine - Product Code DTQ
  • Reason
    The units may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.
  • Action
    Consignees were notified via letter dated 7/18/08 and instructed to use the central control module should the problem occur. Contact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.

Device

Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 0006 through 0066, 0100 through 0322 and 1001 through 1017.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. || For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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