Events

Recall of Device Recall Advanced Perfusion System 1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    59581
  • Event Risk Class
    Class 2
  • Event Number
    Z-0299-2012
  • Event Initiated Date
    2011-11-08
  • Event Date Posted
    2011-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104991
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    1 us customer was operating the advanced perfusion system 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the sarns modular perfusion system 8000 . five(5)of twelve(12) cables from terumo japan, which were in product development, were given to a us customer.
  • Action
    Terumo sent an URGENT MEDICAL DEVICE CORRECTION: Recall Notification dated November 8, 2011 to all affected customers. The letter described the reason for the recall, known/potential hazards and request immediate location and correction of product. The letter instructs customers to stop using the modified cables and return to Terumo for replacement and destruction. Customers were asked to complete the attached response form and fax to the number indicated on the form. All affected customers will be receiving a safety advisory to advise them that Terumo do not recommend the alternative configuration of a System 1 Base with an 8K Occluder. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818 or 1-800-292-6551 (fax).

Device

Device Recall Advanced Perfusion System 1
  • Model / Serial
    Lot numbers: 0006-1415; Catalog # 801764 System 1 Base, 220 V
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - (USA) Nationwide Distribution
  • Product Description
    The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V || Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA