Events

Recall of Device Recall 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
    61231
  • Event Risk Class
    Class 2
  • Event Number
    Z-1964-2012
  • Event Initiated Date
    2012-06-22
  • Event Date Posted
    2012-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107622
  • 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) received two complaints related to the gas system for the terumo advanced perfusion system 1. both were reported instances of users experiencing difficulty adjusting the system 1 gas system local flow control knob.
  • Action
    Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL-SAFETY ADVISORY" letter dated June 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.

Device

Device Recall Terumo Advanced Perfusion System 1
  • Model / Serial
    catalog number: 801764 and Serial numbers: 0006-0066, 0100-0311, 0313-0322,1001-1027,1100-1434,1436, 1440, and 1441.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, 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 (UAE), and Vietnam.
  • Product Description
    Terumo Advanced Perfusion System 1 || System 1 Base, 220/240 V. || 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. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
  • 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