Events

Recall of Device Recall AngioJet XVG Thrombectomy Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Possis Medical, 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
    38244
  • Event Risk Class
    Class 2
  • Event Number
    Z-1131-2007
  • Event Initiated Date
    2007-06-19
  • Event Date Posted
    2007-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53234
  • 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 - Product Code DXE
  • Reason
    Mislabeling : possis angiojet xvg catheter thrombectomy sets display incorrect information on the outer packaging box and also on the inner sterile tray. the labeling incorrectly states that the unit is indicated for use in coronary vessels. these units should indicated use only for peripheral arteries.
  • Action
    A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.

Device

Device Recall AngioJet XVG Thrombectomy Catheter
  • Model / Serial
    71851, 71852, 71997, 72086, 72539, 73170, 73171, 73646, 73758.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AR, AZ, CA, FL, GA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI, WV
  • Product Description
    Possis AngioJet XVG Thrombectomy Sets, || Model/Order # 105042-001, Sterilized with Ethylene Oxide, || Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used with the new AngioJet Ultra Console)
  • Manufacturer
    Possis Medical, Inc

Manufacturer

Possis Medical, Inc
  • Manufacturer Address
    Possis Medical, Inc, 9055 Evergreen Blvd Nw, Minneapolis MN 55433-5833
  • Source
    USFDA