Events

Recall of Device Recall Destination Renal Guiding Sheath Catheter introducer/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
    76939
  • Event Risk Class
    Class 2
  • Event Number
    Z-2033-2017
  • Event Initiated Date
    2015-11-06
  • Event Date Posted
    2017-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154646
  • 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
    Based on internal investigation and testing that revealed the distal end of certain lots of terumo medical destination¿ products may not contain the labeled 5 cm of coating. while there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
  • Action
    An Urgent Product Bulletin Recall of Terumo Medical Product letter, dated November 6, 2015, was sent to customers. The letter identified the affected product and the reason for the voluntary recall. The letter asked customers to immediately discontinue use and quarantine any of the affected product listed. Customers are to complete the enclosed Contact & Inventory Confirmation Form and e-mail DSRenalRecall@terumomedical.com or fax to 732-412-4121, Attn: Destination Recall. For questions or further information, customers can contact Customer Care at 800-888-3786 or their local sales representative.

Device

Device Recall Destination Renal Guiding Sheath Catheter introducer/Guiding Sheath
  • Model / Serial
    Terumo Product Code - RSR01  Affected Lot Numbers  RN19  RN26  RP03
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Destination Renal Guiding Sheath || Intended for the introduction of interventional and diagnostic devices into the human vasculature.
  • 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