Events

Safety Alert for Titan Stabilizers and Titan 360 Stabilizers

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

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
    2015-01-23
  • Event Date Posted
    2015-01-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150123.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: terumo cvs titan stabilizers and titan 360 stabilizers medical device manufacturer, terumo cardiovascular systems (terumo cvs) corporation has issued a field safety notice concerning its titan stabilizers and titan 360 stabilizers, with the following details: catalogue number: 1) 401-231; 2) 401-231u lot number: 1) 052r; 2) 020r, 024r, 026r, 029r, 030r, 034r, 035r, 037r, 040r, 048r dates of distribution: 1) 29 march 2013 and 24 march 2014; 2) 7 august 2013 through 17 october 2014 the manufacturer is voluntarily recalling the above lots of titan stabilizers and titan 360 stabilizers because the suction tubing clip may break when it is being attached to the stabilizing arm. although the clip is for convenience purposes and is not required for device operation, there is a potential for broken suction tubing clip fragments to fall into the surgical site. a broken suction tubing clip could delay a surgical cardiac procedure as the surgeon replaces the unit or secures the suction tubing away from the surgical site by other means. if a suction tubing clip breaks and fragments fall into a patient’s body cavity during surgery, the event could lead to a delay in the procedure as the surgeon retrieves the component. this could be complicated by the fact that the clip fragments may have sharp edges and are not radiopaque. the manufacturer has determined that the suction tubing clip material weakened during a re-sterilisation process that occurred for the affected lots listed. the manufacturer’s current sterilisation process mitigates this risk. the manufacturer advises users to stop using titan stabilizers and titan 360 stabilizers from the affected lot numbers and return all affected product to the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 january 2015.

Device

Titan Stabilizers and Titan 360 Stabilizers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo CVS Titan Stabilizers and Titan 360 Stabilizers
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems