Events

Recall of Device Recall The Terumo Advanced Perfusion System 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
    60463
  • Event Risk Class
    Class 2
  • Event Number
    Z-0839-2012
  • Event Initiated Date
    2012-01-13
  • Event Date Posted
    2012-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105471
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    Terumo cardiovascular systems (terumo cvs) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. the assembly is used in the 4" and the 6" roller pumps for the terumo advanced perfusion system 1.
  • Action
    TERUMO sent an Urgent Medical Device Correction letter dated January 13, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to 1-900-292-6551. Roller pumps with affected cables will have the cables assembly replaced. For questions regarding this recall call 1-800-521-2818.

Device

Device Recall The Terumo Advanced Perfusion System 1
  • Model / Serial
    Catalog Number 816570; Serial Numbers: 5939 - 5962
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MD, WI, and IA and the countries of Canada, Mexico, and Vietnam
  • Product Description
    Roller Pump, 4 Inch Diameter || The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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