Recall of ComboMap Intravascular Flow and Pressure System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volcano Corp.

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
    71404
  • Event Risk Class
    Class 2
  • Event Number
    Z-2045-2015
  • Event Date Posted
    2015-07-08
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-07-09
  • Event Source
    USFDA
  • Event Source URL
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    A limitation in interoperability between the philips xper flex cardia physiomonitoring system and volcano's ss/si, core, and combomap systems. this limitation may impact the calculation of fraction flow reserve (ffr) within the volcano system when the system is connected to the xper flex cardia system via its aortic pressure auxiliary output.
  • Action
    Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.

Device

  • Model / Serial
    Product/Part numbers: Combo Map - 802745-001.  All software versions
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
  • Product Description
    ComboMap Intravascular Flow and Pressure System; || Product/Part number: Combo Map - 802745-001. || Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Volcano Corp, 3721 Valley Centre Dr Ste 500, San Diego CA 92130-3328
  • Manufacturer Parent Company (2017)
  • Source
    USFDA