Z-0800-2012

Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558

Name: Z-0800-2012 Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558
Creator: CareFusion 209 Inc.
Published: 2011-10-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-10-05 / Terminated / root cause: manufacturing process

FDA source

CareFusion 209 Inc. began a recall of Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit... on 2011-10-05. The reason FDA records is "CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0800-2012
Status: Terminated
Initiated: 2011-10-05
Posted: 2012-01-26
Terminated: 2012-05-21
Recalling firm: Medtronic, Inc.
Product: Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.
Product code: GYC Electrode, Cortical
Reason for recall: CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also, it has been determined that the stimulus cable connection in the Cortical S
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: CareFusion sent an "Urgent: Field Safety Corrective Action Notification" letter dated October 5, 2011 to all affected consignees. The letter described the product, the problem and urgent actions to be taken. Consignees were advised to immediately provide their customers with the attached customer notification letter. Consignees were instructed to complete and return the Verification Form enclosed in the notice. For questions on this matter call 1-800-356-0007 ext. 5129.
Quantity in commerce: 52 units
Distribution: Worldwide Distribution - USA (nationwide) including the states of: AR, CA, FL, GA, HI, KY, MI, MO, NY, TX and WA and the countries of: CANADA, CHILE, CHINA, COATIA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, KOREA, NORWAY, PORTUGAL, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, RUSSIA and UNITED KINGDOM.
Product codes and lots: CS09350168 CS09350168 CS-09140115 CS-09140135 CS-09140114 CS09160139 CS-09160155 CS-09070102R CS-09350179 CS-09350177 CS-09160147 CS-09160113 CS09140119 CS0916148 CS09350165 CS09140132 CS-09140122 Unknown Unknown CS-09350173 CS-09160136 CS-09160153 CS09350181 CS09350183 CS-09070109 RA090266M CS-09350171 C64SSU100081-0 CS-09350172 CS09140128 CS-09350174 CS-09350170 CS-09140111 Unknown CS-09160152 Unknown Unknown CS-09160141 CS-09160144 Unknown Unknown CS-09140117 CS09140112 CS-09160158 CS-09160123 CS-09160137 CS-09160126 CS-09140127 CS09350164 CS09140125

Product code GYC

K072964Class IINicolet Cortical StimulatorCardinal Health, Inc. / cleared 2008-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)