Events

Recall of Device Recall ViperWire Advance Peripheral Guide Wire with Flex Tip

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

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
    76784
  • Event Risk Class
    Class 2
  • Event Number
    Z-1771-2017
  • Event Initiated Date
    2017-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154177
  • 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, peripheral, atherectomy - Product Code MCW
  • Reason
    Cardiovascular systems, inc. is recalling one lot of viperwire advance with flextip, model vpr-gw-ft18 because it may contain a 0.014" viperwire advance flextip product instead of the 0.018" viperwire advance with flextip.
  • Action
    Customers were sent an Urgent Medical Device Recall letter beginning March 03, 2017. The letter identified affected product, reason for recall, and asked for affected devices to be removed from use and return to CSI. Questions can be directed to CSI Customer Service at 877-274-0901, or your CSI Sales Representative.

Device

Device Recall ViperWire Advance Peripheral Guide Wire with Flex Tip
  • Model / Serial
    Lot 156032
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
  • Product Description
    ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. || The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
  • Manufacturer
    Cardiovascular Systems Inc

Manufacturer

Cardiovascular Systems Inc
  • Manufacturer Address
    Cardiovascular Systems Inc, 1225 Old Highway 8 NW, Saint Paul MN 55112-6416
  • Manufacturer Parent Company (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA