Events

Recall of ATLAS GOLD PTA DILATATION CATHETER

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
    22287
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-10
  • 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
    To inform customers that specific product code / lot number combinations may be at risk of having a balloon wall thickness that is higher than the required specification which could result in a slight increase in the force required to advance the balloon through the sheath and/or withdraw the balloon after inflation and deflation and could potentially lead to a slight prolongation of the procedure. potentially there may also be an increase in the balloon's non-compliance and rigidity. product return is not required.

Device

ATLAS GOLD PTA DILATATION CATHETER
  • Model / Serial
    Model Catalog: ATG120182 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120162 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120244 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG80164 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG80202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG80222 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120184 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    ATLAS GOLD PTA DILATATION CATHETER
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.