Events

Recall of Destination Guiding Sheath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Medical 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
    79167
  • Event Risk Class
    Class 2
  • Event Number
    Z-0725-2018
  • Event Initiated Date
    2017-09-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161503
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    The tucking depth feature of this catheter introducer is marginally outside the upper specification.
  • Action
    Terumo sent an Urgent Medical Device Recall dated September 12, 2017 to affected customers. The letter identified the affected product problem and actions to be taken. The informed customers that a territory managers will visit each institution to examine the inventory, identify the affected product and lot, and prepare the product for return to Terumo Medical Corporation. There is an inventory confirmation form that is returned by the sales representative to the recalling site.

Device

Destination Guiding Sheath
  • Model / Serial
    Lot: VK09, Expiration Date: 31-Jan-2020
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    To be added.
  • Product Description
    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 || Product Usage: || The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Manufacturer Address
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA