Events

Recall of MOBICATH Bi-Directional Guiding Sheath, small curve (used to introduce cardiovascular catheters)Small Curve

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

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
    RC-2012-RN-01173-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01173-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer observed some anomalies of the inner lumen of these products during visual inspection utilising a new inspection tool. the anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string like liner material (from scratches or damage on the inner wall of sheath lumen).
  • Action
    Quarantine and return affected devices to Johnson & Johnson Medical.

Device

MOBICATH Bi-Directional Guiding Sheath, small curve (used to introduce cardiovascular catheters)S...
  • Model / Serial
    MOBICATH Bi-Directional Guiding Sheath, small curve (used to introduce cardiovascular catheters)Small CurveProduct Number: D140010All lotsARTG Number: 191013
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd