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
    36498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0494-2007
  • Event Initiated Date
    2006-10-16
  • Event Date Posted
    2007-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48749
  • 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
    The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.
  • Action
    Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.

Device

Terumo APS 1
  • Model / Serial
    Serial numbers 0023 through 0026, 0034, 0041, 0051, 0060, 0063 through 0065, 0067 through 0069, 0071 through 0089, 0091 through 0139, 0141 through 0242, 0246 through 0280, 0282 through 0297, 0299 through 0323, 0325 through 0393, 0395 through 0421, 0423 through 0436, 0440 through 0469, 0471 through 0530, 0532 through 0550, 0552 through 0569, 0571 through 0578, 0582 through 0661, 0664 through 0666, 0668 through 0731, 0734 through 0794, 0796 through 0807, 0813 through 0817, 0820 through 0857 and 0859 through 0896.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- including USA and countries of 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; Air Bubble Detection Module; Catalog number 802110.
  • 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