Software glitches and a short-circuit risk have prompted the FDA to issue a Class 1 recall of CareFusion’s Nicolet functional brain-mapping device and its associated software. The products are used to guide surgery on patients with seizure disorders and brain tumors.
According to the FDA, the device’s software incorrectly indicates delivery of stimulation to a different electrode than the one selected. Meanwhile, a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. “Both of these issues may result in the surgeon resecting the wrong brain tissue,” said the FDA. “The surgeon may also fail to resect pathological tissue, potentially leading to continued pathologic processes and the need for re-operations.”
The recall comes nearly five months after CareFusion sent its Nicolet customers a letter describing “urgent field safety corrective” actions that needed to be taken to ensure efficacy and safety.
The affected products—the Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License—were manufactured between May 7, 2009, and July 11, 2011. The recall affects 132 devices and 35 software licenses.
CareFusion is based in San Diego.