Codman Announces Voluntary Recall of CERTAS™ Programmable Valve

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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.

9 Comments for : Codman Announces Voluntary Recall of CERTAS™ Programmable Valve
  1. Reply

    young son had a codman shunt installed.

    • Burgundy Vice
    • July 9, 2017
    Reply

    Hi,
    I have the Codman Certus plus, and I had a valve malfunction, and had to have valve replaced. Is this due to the recall? I was having pressure headaches. Procedure was just performed on July 3, 2017

    • Gina Spencer
    • September 27, 2016
    Reply

    Are they using the Codman Certas Valve any longer since the recall, or is the Codman Certas “plus” used now in place of the one that was a problem with MRI sensitivity? Please advise. Also I notice that the Certas was only able to work in MRI up to 3 Teslas, and the Certas plus is 4 Teslas. Is this accurate information?

    • Gina Spencer
    • September 27, 2016
    Reply

    My Father just had this valve installed on 7/7/2016. Is it necessary for him to use caution when he has an MRI scheduled for next week or two, to have precautions taken to ensure that the valve setting does not change during the MRI procedure?

    • Erika Mathis
    • August 18, 2016
    Reply

    I have a codman certas and had an MRI. It changed my setting from 5 to 2 and I am currently overdraining. My surgeon changed the setting now to 4 and after about 16 hours my pressure has notnchanged. My surgeon put me on an icp monitor when my shunt was the 2 to see the pressure and the pressure is still the same at 4. Could the mri have damaged the valve and it is not working correctly now?

    • robert hawkins
    • July 27, 2016
    Reply

    I ,Robert Hawkins
    I have a Certas Programmable valve was put in at Cleveland clinic Fairview hospital on 7-8-16 so far everything is doing very well.DR.Voster

    • Wesley Huson
    • June 21, 2016
    Reply

    i had this recalled shunt in me, ended up in mri my shunt got blocked and changed setting then ended up in icu with mengitis had 14 brain surgerys due to this recall

    • Vicki Breslin
    • June 5, 2016
    Reply

    Please tell me the date of the recall for the Codman CERTAS™ valves. Yesterday does me no good since I don’t know when yesterday was. Friday June 3, 2016, I was told doctor will be using the Codman CERTAS PLUS on June 20, 2016

  2. Reply

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