Events

Recall of Device Recall Pinnacle Destination Guiding Sheath, 6 French, 90 cm

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
    58677
  • Event Risk Class
    Class 2
  • Event Number
    Z-2415-2011
  • Event Initiated Date
    2010-06-24
  • Event Date Posted
    2011-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99892
  • 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
    Molding defect in destination product that render the device unusable.
  • Action
    Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

Device

Device Recall Pinnacle Destination Guiding Sheath, 6 French, 90 cm
  • Model / Serial
    RSC01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
  • Product Description
    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
  • 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