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Health professionals and consumers are advised that Johnson & Johnson Medical, after consultation with the TGA, has initiated a recall of all unused stock and issued a hazard alert to implanting surgeons for the following two Codman Certas Programmable Valve products:
| Code | Description |
|---|---|
| 82-8804 | In Line Valve only with SIPHONGUARD device |
| 82-8806 | In Line Valve with SIPHONGUARD, unitised catheter and accessories |
Codman Certas Programmable Valves are single-use implantable devices, designed to drain excess cerebrospinal fluid from the brain and carry it to other parts of the body for the treatment of hydrocephalus (also known as 'water on the brain'). The valves can be programmed to eight different settings.
It has been identified that, in a small percentage of Codman Certas Programmable Valves listed above, the following faults may occur:
- the magnetic resonance imaging (MRI) resistance feature may not always operate properly, which could result in unintended changes in the valve setting if the patient is exposed to an MRI procedure or other strong magnetic fields
- the programming mechanism may not always operate properly, which could result in an inability to change the valve setting.
Information for consumers
Johnson & Johnson Medical has contacted the implanting surgeons and the hospitals where the devices have been implanted, providing further information regarding this recall and advice on how to treat affected patients.
If you have had a Codman Certas Programmable Valve implanted and have any questions or concerns, please contact your surgeon or the hospital where the device was implanted.
Please note, in most cases removal/replacement of an affected device is not likely to be needed for patients who already have one implanted.
Information for health professionals
Patients who have had a Codman Certas Programmable Valve implanted and who have any questions or concerns about the above issues should be referred to the implanting surgeon or the hospital where the device was implanted.
Johnson & Johnson Medical has contacted the implanting surgeons and the hospitals where the devices have been implanted, providing further information regarding this recall and advice on how to treat affected patients.
The advice regarding treating affect patients includes:
- Follow the Instructions for Use (IFU), which recommend verifying the settings of implanted valves after exposure to an MRI.
- If the implanting surgeon encounters any difficulties with the programming mechanism, try to re-program the device using the hand-held Codman Certas Therapy Management System, as outlined in the IFU. If additional attempts are unsuccessful, they should contact their Codman Neuro representative for further support.
The hospitals have been instructed to check their inventory to see if they have any affected devices in stock and, if so, to quarantine the devices before returning them to Johnson & Johnson Medical.
If you have any questions or concerns about this issue, or to make arrangements to return affected devices, call Johnson & Johnson Medical Customer Service on 1800 252 194.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.