Events

Safety Alert for Codman CERTAS Programmable Valves

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

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
    2013-05-21
  • Event Date Posted
    2013-05-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130521.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: codman certas programmable valves the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning codman certas programmable valves, manufactured by medos international sarl. the affected devices included in line valve only with siphonguard device [product code: 82-8804] & in line valve with siphonguard, unitized catheter and accessories [product code: 82-8806]. testing has shown that, in a small percentage of valves, the following conditions may exist: the mri resistance feature may not always operate properly. if this occurs, it could potentially result in an unintended change in the valve setting due to exposure to an mri procedure or other magnetic field. based on reported complaints, this issue may have been a factor in up to 0.06% of units sold. the programming mechanism may not always operate properly. if this occurs, it could potentially lead to an inability to modify the operating pressure of the valve with the hand-held programming tools, also referred to as the codman certas therapy management system (tms). based on reported complaints, this issue may have been a factor in up to 0.4% of units sold. the manufacturer is recalling the affected units that have not been implanted. for patients that have already been implanted with the device, the manufacturer is providing additional instructions to clinicians to identify whether the implanted device has been affected and what to do if the device has been affected. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00473-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 may 2013.

Device

Codman CERTAS Programmable Valves
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Codman CERTAS Programmable Valves
  • Manufacturer
    Medos International SARL

Manufacturer

Medos International SARL