Events

Recall of Terumo APS 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
    36396
  • Event Risk Class
    Class 2
  • Event Number
    Z-0325-2007
  • Event Initiated Date
    2004-10-12
  • Event Date Posted
    2006-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48577
  • 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 DTQ
  • Reason
    Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'x' being displayed on the monitor screen.
  • Action
    U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Device

Terumo APS 1
  • Model / Serial
    Serial numbers 0033, 0034, 0036, 0038, 0041 through 0043, 0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098, 0099, 0102 through 0116, 0118, 0124, 0127 through 0136, 0138 through 0146, 0148 through 0151, 0153 through 0163, 0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187, 0189 through 0200, 0202 through 0231, 0233 through 0240, 0242 through 0278, 0281 through 0302, 0304 through 0481, 0483 through 0587, 0700 through 0753, 0757, 0758, 0760 through 0769, 0771 through 0787, 0789 through 0793, 0795 through 0866, 0868 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1001, 1004 through 1015, 1017, 1019 and 1024 through 1027.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
  • 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