Events

Recall of Volcano FloWire Doppler Guidewire

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
    60842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0935-2012
  • Event Initiated Date
    2009-10-06
  • Event Date Posted
    2012-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106630
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    Reports of no signal displayed on the monitor when flowire doppler guide wires were connected to the combomap.
  • Action
    Volcano Corporation sent recall letters dated October 6, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and fax the attached Customer Reply Letter so that an RMA could be issued for the return of the unused affected product, and any replacement or credit could be arranged. Customers were instructed to return the Customer Reply letter even if they no longer have the affected product in their inventory. For questions regarding the use of the product. customers were instructed to contact their Sales Representative. For questions regarding this recall call 916-281-2790.

Device

Volcano FloWire Doppler Guidewire
  • Model / Serial
    Part number 1400; Serial numbers 011-0318-002; 011-01323-012; 011-01319-001; 011-01319-002, 011-01319-005, 011-01319-006; 011-01319-007; 011-01318-001, 011-01321-003, 011-01321-006; 011-01321-008; 011-01321-009; 011-01322-001, 011-01323-010.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MI, AZ and FL and the countries of Japan and Europe
  • Product Description
    FloWire Doppler Guide wires. || Volcano Corporation, || Rancho Cardova, Ca. || The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures.
  • 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