Codman Certas Programmable Valves (Hydrocephalic valve) In Line Valve only with SIPHONGUARD Device, In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 의 리콜

Recall

RC-2013-RN-00473-1

Class I

2013-05-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00473-1

Johnson & johnson testing has shown that, in a small percentage of valves, the following conditions may exist:1. 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.2. 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.

JJM is recalling the affected units that have not been implanted. For patients that have already been implanted with the device, JJM is providing additional instructions to clinicians to identify whether the implanted device has been affected and what actions to undertake if the device has been affected. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-130527.htm . This action has been closed-out on 29/01/2016.