Events

Recall of MAXXUM PTCA DILATATION CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOSTON SCIENTIFIC SCIMED.

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
    109177
  • Event Risk Class
    III
  • Event Initiated Date
    1999-06-15
  • Event Country
    Canada
  • 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
    This product packaged with viva balloon catheter instructions for use and the wrong colour viva shelf box.

Device

MAXXUM PTCA DILATATION CATHETER
  • Model / Serial
    Model Catalog: MAX20/2.0 (Lot serial: 2117966 EXP. JAN. 2001)
  • Product Description
    MAXXIM PTCA DILATION CATHETER
  • Manufacturer
    BOSTON SCIENTIFIC SCIMED

Manufacturer

BOSTON SCIENTIFIC SCIMED
  • Manufacturer Address
    MAPLE GROVE
  • Source
    HC