Codman announced yesterday that it has made a proactive decision to recall any CERTAS™ programmable valves still in stock at hospitals and medical facilities. According to Codman, this recall was not initiated as a result of reported problems with the shunt in patients. In a letter to neurosurgeons and neurologists, Codman stated that this was a voluntary decision based on a very small percentage of possible cases where the valve setting could change after an MRI procedure, or a problem could arise when trying to use the hand-held programming tool.
Many of you are undoubtedly asking what this recall means to you. As is the case with most programmable shunts, your setting can change following an MRI procedure. Codman has marketed the CERTAS™ valve as MRI resistant, necessitating the recall. You should know what type of shunt you have and the current setting. If you are scheduled for an MRI procedure or need to undergo an emergency procedure, always make sure that your shunt settings are checked and verified afterwards by your neurosurgeon or neurologist.
It is important to note that the Codman HAKIM® programmable valve series and the Codman fixed-pressure valves are not included in this recall. The CERTAS™ valve was first made available in the U.S. beginning in November, 2011.
If you have a Codman CERTAS™ valve, you may receive a communication directly from your neurosurgeon or neurologist. At present, Codman is in the process of contacting doctors and hospitals, which will take a couple of days. The Hydrocephalus Association will be working with our Medical Advisory Board and Codman to provide additional information early next week.
May 17, 2013