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U.S. Department of Health and Human Services

Medical Devices

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CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit

Recall Class: Class I

Date Recall Initiated: October 5, 2011

Product: Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. 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.

Use: The affected devices and software aid in the identification and mapping of areas of the brain. These products are used for functional brain mapping procedures by physicians and surgeons in the treatment of patients with seizure disorders and brain tumors.

Recalling Firm:
CareFusion 209 Inc.
1850 Deming Way
Middleton, Wisconsin 53562

Reason for Recall: CareFusion is recalling these affected devices and software for two reasons:

  • The device’s software incorrectly indicates stimulation is delivered to a different electrode than the one selected
  • 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.

Public Contact: Affected customers with questions may contact CareFusion Technical Support, toll-free at 1-800-356-0007 (option 2).

FDA District: Minneapolis

FDA Comments: CareFusion sent consignees an Urgent Field Safety Corrective Action Notification letter,disclaimer icon dated October 5, 2011.

The letter describes actions NicoletOne software users should take, including completing and returning a verification form.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

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.