Events

Recall of Device Recall Diamondback 360, CSI ViperWire

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
    51499
  • Event Risk Class
    Class 2
  • Event Number
    Z-1250-2009
  • Event Initiated Date
    2009-03-16
  • Event Date Posted
    2009-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80555
  • 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
    Peripheral Catheter Atherectomy - Product Code MCW
  • Reason
    Csi is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. the labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.
  • Action
    Customer letters were FedEx'd to CSI Sales Professionals on 03/16/2009, who delivered the letters and helped coordinate the removals of affected product. The letter identified the product, provided a description of the issue and provided instructions to immediately remove from use and return the affected guidewires to CSI. A Customer Acknowledgement Form was asked to be completed and returned with the devices.

Device

Device Recall Diamondback 360, CSI ViperWire
  • Model / Serial
    Lot: P1406641
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.
  • Manufacturer
    Cardiovascular Systems, Inc.

Manufacturer

Cardiovascular Systems, Inc.
  • Manufacturer Address
    Cardiovascular Systems, Inc., 651 Campus Dr, Arden Hills MN 55112-3495
  • Manufacturer Parent Company (2017)
    Cardiovascular Systems Inc.
  • Source
    USFDA