| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00816-1 |
| Product Name/Description |
Codman Certas Programmable Valves (Hydrocephalic valve)
In Line Valve only with SIPHONGUARD Device
Product Code: 82-8804
In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories
Product Code: 82-8806
All lot numbers
ARTG Numbers: 186235 and 190248 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
The virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm H2O. Recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm H2O. This testing found only one occurrence out of 72 test instances that was significantly below 400mm H2O (observed at 275mm H20), although when retested, this valve performed above 400mm H2O. If a valve is considered to be virtually off, but is still operating at a physiologically relevant pressure, a clinician may inaccurately consider the patient to be shunt independent. This may result in a delay in treatment for shunt-related complications. If the virtual off setting is being used to restore ventricular volume for patients with Slit Ventricle Syndrome or subdural haemorrhage formation resulting from overdrainage, treatment response may be delayed for valves operating significantly below 400mm H2O. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised that:
· no action is required if patient is experiencing good outcomes with an implanted valve
· be aware that symptoms resulting from this issue would be similar to those seen in the standard course of treatment, so it can be difficult to directly correlate complaints with this problem
· If the Virtual Off setting is being used to address an acute overdrainage situation that has resulted in subdural haemorrhage or slit ventricle formation, close observation is advised to make sure that the patient is responding as expected (operating pressure 400mm H2O).
Please note that the manufacturer, Codman Neuro is not recommending explanation of CODMAN CERTAS Valves. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-140729.htm This action has been closed-out on 06/06/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Toll Free |