Events

Recall of Diamondback 360 Orbital Atherectomy Device

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
    52810
  • Event Risk Class
    Class 2
  • Event Number
    Z-2028-2009
  • Event Initiated Date
    2009-04-16
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84051
  • 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
    Csi is correcting (8) packages of diamondback 360 due to a missing "use by date" on the device labeling. the labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. the units affected by this correction are sterilized products, and csi believes that there is no immediate risk to health associated with these distributed products recognizing the valid s.
  • Action
    Cardiovascular System, Inc. issued an "URGENT: Medical Device Correction" letter dated April 16, 2009. The letter described the product and the problem. The letter informed the consignees that the "Device" re-labeling would be performed by company representatives. Devices will not be returned. For further information, contact Cardiovascular System, Inc. 1-877-274-0901.

Device

Diamondback 360 Orbital Atherectomy Device
  • Model / Serial
    Lot Number: 23181.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, GA, MI, NY, NY and TN.
  • Product Description
    Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 || Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. || The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.
  • 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