Events

Recall of Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.

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
    31489
  • Event Risk Class
    Class 2
  • Event Number
    Z-0666-05
  • Event Initiated Date
    2005-03-17
  • Event Date Posted
    2005-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37978
  • 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 pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero rpm while the pump is operating in pulse mode.
  • Action
    Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded.

Device

Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
  • Model / Serial
    Serial numbers 0028 through 0527 and 0700 through 0874.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malasia, Mexico, Pakistan, South Africa, South Korea, Taiwan, Thailand and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); 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