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
    44850
  • Event Risk Class
    Class 2
  • Event Number
    Z-0671-2009
  • Event Initiated Date
    2007-11-20
  • Event Date Posted
    2009-01-29
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2009-08-06
  • Event Source
    USFDA
  • Event Source URL
  • 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 console. - Product Code DTQ
  • Reason
    The system may malfunction due to t-filter corrosion on an internal circuit board.
  • Action
    U.S. consignees were notified of the problem by letter on 11/16/07. International affiliates were informed via email on 11/21/07. Consignees were informed that Terumo would schedule appointments to install new pressure modules and reconfigure the systems beginning in Feb. 2008 or that parts would be shipped to consignees wishing to perform the work themselves. For additional information, contact Terumo CVS Customer Service at 1-800-521-2818.

Device

  • Model / Serial
    Serial numbers 00001 through 01246, 01257 through 01277, 01279 through 01286, 01288 through 01295, 01298 through 01308, 01310 through 01315 and 01319 through 01320.
  • Product Classification
  • 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, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802112. || For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
  • Manufacturer

Manufacturer

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