CareFusion NicoletOne Software and Nicolet devices has been named in a Class I recall, the U.S. Food and Drug Administration (FDA) just announced.
Class I recalls are the most serious type of recall and involve situations in which there exists a reasonable probability that use of the recalled product—in this case, CareFusion NicoletOne Software, which is used with the CareFusion Cortical Stimulator Control Unit—will cause serious adverse health consequences or death.
The Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier, and NicoletOne Software with Cortical Stimulator License are involved in this recalled. The involved devices and software were manufactured from May 7, 2009 through July 11, 2011 and include 132 devices and 35 software licenses.
The affected devices and recalled software aid in the identification and mapping of areas of the brain and are used for functional brain mapping procedures by physicians and surgeons who treat patients diagnosed with seizure disorders and brain tumors.
CareFusion 209 Inc. is recalling the Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier, and NicoletOne Software with Cortical Stimulator License because the device’s software incorrectly indicates stimulation is delivered to a different electrode than the one selected and a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier.
These issues may result in the surgeon resecting the wrong brain tissue or may cause the surgeon to fail to resect pathological tissue, which can potentially lead to continued pathologic processes and the need for additional surgeries.
CareFusion, which is located at 1850 Deming Way Middletown, Wisconsin 53562, can be reached via its Technical Support group, toll-free, at 1.800.356.0007; option 2.
CareFusion sent consignees an Urgent Field Safety Corrective Action Notification letter, dated November 5, 2011, and which describes actions that NicoletOne software users should take, such as completing and returning a verification form.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX. Information can be accessed at the agency’s website at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.