Events

Recall of Device Recall ViperWire Advance peripheral guide wire

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
    74445
  • Event Risk Class
    Class 2
  • Event Number
    Z-2051-2016
  • Event Initiated Date
    2016-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147593
  • 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
    The pouch label was missing the use by date (ubd) of 2018-04.
  • Action
    Consignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112.

Device

Device Recall ViperWire Advance peripheral guide wire
  • Model / Serial
    Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution.
  • Product Description
    ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.
  • Manufacturer
    Cardiovascular Systems Inc

Manufacturer

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