Events

Recall of TORFLEX TRANSSEPTAL GUIDING SHEATH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYLIS MEDICAL COMPANY 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
    32870
  • Event Risk Class
    I
  • Event Initiated Date
    2010-02-09
  • 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
    In some instances the transseptal introducer sheath radiopaque/soft tip may fracture or detach during in vivo use resulting in device fragment that can pass into the systemic arterial circulation and lead to an embolic event.

Device

TORFLEX TRANSSEPTAL GUIDING SHEATH
  • Model / Serial
    Model Catalog: TF8-38-62-S (Lot serial: S22739); Model Catalog: TF8-38-62-S (Lot serial: S22739X1); Model Catalog: TF8-38-62-S (Lot serial: S21903); Model Catalog: TF8-38-62-S (Lot serial: S21940); Model Catalog: TF8-38-62-S (Lot serial: S21244)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    TorFlex Transseptal guiding Sheath
  • Manufacturer
    BAYLIS MEDICAL COMPANY INC.

Manufacturer

BAYLIS MEDICAL COMPANY INC.