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CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short Circuit

Thu, 02/23/2012 - 7:30am
U.S. Food & Drug Administration

AUDIENCE: Neurology, Risk Managers

ISSUE: CareFusion is recalling Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License for two reasons: 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.  Both of these issues may result in the surgeon resecting the wrong brain tissue. The surgeon may also fail to resect pathological tissue, potentially leading to continued pathologic processes and the need for re-operations.

BACKGROUND: 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.

RECOMMENDATION: CareFusion sent consignees an Urgent Field Safety Corrective Action Notification letter, which described actions NicoletOne software users should take.  Affected customers with questions may contact CareFusion Technical Support, toll-free at 1-800-356-0007

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/22/2012 - Recall - FDA]

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