Events

Recall of Device Recall Terumo 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
    62367
  • Event Risk Class
    Class 2
  • Event Number
    Z-1968-2012
  • Event Initiated Date
    2012-06-25
  • Event Date Posted
    2012-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110339
  • 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
    Terumo cardiovascular systems (terumo cvs) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. if it is.
  • Action
    The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" notification dated June 25, 2012 and an update to the Operator's Manual for the Terumo Advanced Perfusion System 1 via Federal Express to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review this Medical Device Recall notice; assure that all users are aware of this notice; place the addendum at the beginning of the Roller Pumps Section (page 5.1) of the Operator's Manual, and complete and return the attached Customer Response Form to the fax number/email address indicated on the form. Note: Terumo is continuing its investigation into the root cause of the malfunctions, and may initiate further action pending results of the investigation. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours: Monday-Friday, 8 AM - 6 PM (ET).

Device

Device Recall Terumo Advanced Perfusion System 1
  • Model / Serial
    catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Product Description
    System 1 Base 100/120V || The Terumo 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, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • 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