Events

Recall of Device Recall IVUS Catheter

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
    71881
  • Event Risk Class
    Class 2
  • Event Number
    Z-2718-2015
  • Event Initiated Date
    2015-07-22
  • Event Date Posted
    2015-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139266
  • 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 for crossing total occlusions - Product Code PDU
  • Reason
    Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the pioneer plus intravascular ultrasound guided re-entry catheters.
  • Action
    The Volcano Corporation sent an Urgent Medical Device Recall letter dated July 22, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine and return all affected product in their inventory. Customers were also asked to complete the attached form and fax back to 866-723-2482. Customers with questions were instructed to call 866-861-8923. For questions regarding this recall call 978-439-3586.

Device

Device Recall IVUS Catheter
  • Model / Serial
    Product Code PPLUS20; All lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
  • Product Description
    Volcano Pioneer Plus Re-Entry Catheter; || Product Code PPLUS20, Catheter for Crossing Total Occlusions. || Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.
  • 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