CareFusion Cortical Stimulator Recall Due to Software Malfunction & Short Circuit
The U.S. Food & Drug Administration announced today that CareFusion is recalling Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator Software License. The product is being recalled for two reasons:
1) The device’s software incorrectly indicates that stimulation is delivered to a different electrode than the one selected.
2) A short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier.
According to the FDA, both of these issues may result in the surgeon resecting the wrong brain tissue and/or failing to resect pathological tissue, potentially leading to continued pathologic processes and the need for re-operations.
These products are used for functional brain mapping procedures by physicians and surgeons in the treatment of patients with seizure disorders and brain tumors. The affected devices and software aid in the identification and mapping of areas of the brain. The affected devices and software were manufactured from May 7, 2009 through July 11, 2011. 132 devices and 35 software licenses were affected by this recall.
If you or a loved one has been injured after undergoing surgery or treatment in which the CareFusion Cortical Stimulator was used, you may be entitled to compensation. We would be happy to review your records to determine if you have a viable case against CareFusion. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.
