Events

Recall of 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 Corp.

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
    27604
  • Event Risk Class
    Class 2
  • Event Number
    Z-0103-04
  • Event Initiated Date
    2003-10-16
  • Event Date Posted
    2003-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30167
  • 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
    The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
  • Action
    Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.

Device

Terumo Advanced Perfusion System 1
  • Model / Serial
    Serial numbers 0001 through 0599.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea.
  • Product Description
    Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA