Events

Recall of Device Recall XSizer Thrombectomy Catheter System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ev3, 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
    34708
  • Event Risk Class
    Class 3
  • Event Number
    Z-1108-06
  • Event Initiated Date
    2006-02-14
  • Event Date Posted
    2006-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44538
  • 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
    Thrombectomy Catheter System - Product Code MCW
  • Reason
    Loss of operating vacuum during use-it has been determined that a small percentage of x-sizer thrombectomy catheter systems from specific lots may lose operating vacuum prematurely due to a system leak within the control module. this failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
  • Action
    A medical Device Recall Letter dated 02/13/06 was sent to hospitals along the affected device lot numbers the hospital should have received on a Device Reconciliation Form. ev3 is asking for affected devices to be returned. Returned devices will be replaced at no cost.

Device

Device Recall XSizer Thrombectomy Catheter System
  • Model / Serial
    Model number XD-CS1200-55 (for US distribution) lot numbers: 782706, 782707, 782708, 782708, 782708, 782718, 782724, 986901, 986902, 986904, 986908, 986909, 986910, 986911, 986912, 986915, 986916, 986918, 986919, 986921, 986922, 986922, 986922, 986922, 986922, 986925, 986932, 986934, 1130582, 1156888, 1156888, 1156888, 1212539, 1212540, 1212543, 1215499, 1215500, 1215506, 1215511, 1215511, 1215511, 1215514, 1242336, 1328479, 1328597, 1336891, 1337003.   Model number for XR-CS1200-55 (OUS distribution) lot numbers: 782873, 782875, 782876, 782877, 782878,  782879, 987127, 987128, 987129, 987130, 987131,  987132, 1302736, 1327016, 1344586, 1344591, 1344595,  1344614, 1344624, 1344626, 1344627, 1344633, 1346625,  1346626, 1346651, 1346676, 1346677, 1346678, 1364066,  1364075, 1364081, 1364082, 1364090, 1364099, 1364118,  1364170, 1364179, 1364186, 1364200, 1364226, 1364255,  1364283.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide-AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. OUS to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Jordan, Mexico, Netherlands, Norway, Pakistan, Portugal, Saudi Arabi, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
  • Product Description
    X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA.
  • Manufacturer
    Ev3, Inc

Manufacturer

Ev3, Inc
  • Manufacturer Address
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA