Important Safety Alerts

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