Events

Recall of SAXX STENT

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
    60523
  • Event Risk Class
    III
  • Event Initiated Date
    2006-11-30
  • 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
    Manufacturer does not hold a valid iso certificate and therefore decided to recall these devices.

Device

SAXX STENT
  • Model / Serial
    Model Catalog: PX-S17 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-S10 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M80 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M40 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M13 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M30 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M20 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L80 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L60 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L40 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L30 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L20 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PSS15-6-120 (Lot serial: BETWEEN P0508200 AND P0622400); Model Catalog: PSS15-5-120 (Lot serial: BETWEEN P0508200 AND P0622400); Model Catalog: PSS15-6-75 (Lot serial: BETWEEN P0508200 AND P0622400); Mode
  • Product Description
    SAXX PERIPHERAL STENT
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.