Recall of VACORA VACUUM BIOPSY SYSTEM - CANNULA CANNULA MRI

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    56938
  • Event Risk Class
    II
  • Event Initiated Date
    2009-04-14
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Some vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast.

Device

  • Model / Serial
    Model Catalog: VC10118MR (Lot serial: HUSD2647); Model Catalog: VC10118MR (Lot serial: HUSH0816 HUSI0216 HUSC1588); Model Catalog: VC10118P (Lot serial: HUSA1668 HUSC1533 HUSD1075); Model Catalog: VC10118P (Lot serial: HUSI1063 HUSG0594)
  • Product Description
    VACORA VACUUM BIOPSY SYSTEM - CANNULA
  • Manufacturer

Manufacturer