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
    62373
  • Event Risk Class
    Class 2
  • Event Number
    Z-1970-2012
  • Event Initiated Date
    2012-06-25
  • Event Date Posted
    2012-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110355
  • 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) has received reports of various roller pump malfunctions of the terumo advanced perfusion system 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. description of malfunctions: " unplanned pump stop or pause " changes in pump speed if it is necessary to replace a roller pump during cardiopu.
  • Action
    Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Customer Response Form to the firm via fax at 1-800-292-6551. Contact the firm at 1-800-521-2818 for questions regarding this recall.

Device

Device Recall Terumo Advanced Perfusion System 1
  • Model / Serial
    catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106,1109-1445, and 1447-1450.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, 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
    System 1 Base 100/120V || 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