Events

Recall of Device Recall Terumo Perfusion System 8000

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
    37366
  • Event Risk Class
    Class 2
  • Event Number
    Z-0656-2007
  • Event Initiated Date
    2007-01-12
  • Event Date Posted
    2007-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50424
  • 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
    Perfusion System - Product Code DTW
  • Reason
    The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (note: some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the summer of 2006.).
  • Action
    Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.

Device

Device Recall Terumo Perfusion System 8000
  • Model / Serial
    Hand crank serial numbers 1963 through 1986.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
  • 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