Events

Recall of Device Recall Terumo Cardiovacular

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
    67064
  • Event Risk Class
    Class 2
  • Event Number
    Z-0603-2014
  • Event Initiated Date
    2013-06-04
  • Event Date Posted
    2013-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124644
  • 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
    Valve, pressure relief, cardiopulmonary by Medical - Product Code MNJ
  • Reason
    Over-pressure safety valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
  • Action
    Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.

Device

Device Recall Terumo Cardiovacular
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada
  • Product Description
    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA