Events

Recall of Terumo APS1Perfusion System

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
    36392
  • Event Risk Class
    Class 2
  • Event Number
    Z-0292-2007
  • Event Initiated Date
    2005-10-06
  • Event Date Posted
    2007-01-09
  • 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=48569
  • 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
    Six inch roller pumps were mislabeled as 4 inch roller pumps.
  • Action
    The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.

Device

Terumo APS1Perfusion System
  • Model / Serial
    Serial numbers 0976 and 0979.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-Michigan and Singapore.
  • 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