Events

Recall of 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
    34488
  • Event Risk Class
    Class 2
  • Event Number
    Z-1266-06
  • Event Initiated Date
    2005-09-01
  • Event Date Posted
    2006-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43983
  • 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
    extracorporeal circulation - Product Code DTQ
  • Reason
    The pump may stop during the autodose delivery without completion of the dose delivery to the patient.
  • Action
    Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06.

Device

APS 1
  • Model / Serial
    Serial numbers 0031 through 1188.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 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