Events

Safety Alert for MOBICATH Bi-Directional Guiding Sheath

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Greatbatch Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-11-19
  • Event Date Posted
    2012-11-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121119.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: greatbatch mobicath bi-directional guiding sheath medical device manufacturer, greatbatch ltd., inc., has initiated a voluntary product removal concerning mobicath bi-directional guiding sheath small curve (catalogue no.: d0140010) and mobicath bi-directional guiding sheath large curve (catalogue no.: d0140011). the manufacturer has recently observed some anomalies of the inner lumen of the mobicath sheath during the implementation of a new inspection tool during visual inspection. the anomalies may include loose, string-like liner material, line abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen). to date, there have been no patient injuries, or adverse events reported as a result of this issue and there have been no reported complaints of this type of defect. however, under the worst case scenario, a loose piece of the liner could be introduced into a patient during a procedure and potentially lead to a patient embolic event. for this reason, the manufacturer and the distributor decided to voluntarily recall all lots of the mobicath bi-directional guiding sheath small curve (d140010) and mobicath bi-directional guiding sheath large curve (d140011). according to the local supplier, johnson & johnson (hong kong) ltd., the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 november 2012.

Device

MOBICATH Bi-Directional Guiding Sheath
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Greatbatch MOBICATH Bi-Directional Guiding Sheath
  • Manufacturer
    Greatbatch Ltd.

Manufacturer

Greatbatch Ltd.