Events

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

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-2017-RN-00278-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00278-1
  • 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, greatbatch medical has received reports of a pouch seal integrity issue with a specific lot of mobicath bi-directional guiding sheath. one side of the pouch may not be sealed and as a result, may cause the sterile barrier of the pouch to be compromised. the use of a non-sterile product in surgery could potentially result in adverse health consequences, such as infection, which could lead to life threatening events and/or death. greatbatch has received no reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
  • Action
    JJM is advising users to immediately inspect the device(s) in their possession to determine if their facility has affected product, and then to quarantine the affected product prior to returning it to JJM for replacement.

Device

MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)
  • Model / Serial
    MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)Product Number: D140010Lot Number: W3338707ARTG Number: 191013
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd