Events

Recall of Volcano TrakBack II Disposable Pullback Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volcano 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
    69049
  • Event Risk Class
    Class 2
  • Event Number
    Z-2636-2014
  • Event Initiated Date
    2014-08-13
  • Event Date Posted
    2014-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129418
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • Reason
    Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
  • Action
    Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.

Device

Volcano TrakBack II Disposable Pullback Device
  • Model / Serial
    Part number 91003: All Lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
  • Product Description
    Volcano TrakBack II Disposable Pullback Device; || Sterile and nonpyrogenic; Single Use. || TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Manufacturer Address
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA