Z-0006-2012

Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are...

Name: Z-0006-2012 Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are...
Creator: Cyberonics, Inc
Published: 2011-05-06
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2011-05-06 / Terminated / root cause: software

FDA source

Cyberonics, Inc began a recall of Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of... on 2011-05-06. The reason FDA records is "An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0006-2012
Status: Terminated
Initiated: 2011-05-06
Posted: 2011-10-04
Terminated: 2012-12-04
Recalling firm: LivaNova USA, Inc.
Product: Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm, Cyberonics Inc., initiated containment actions on March 17, 2011 to prevent additional affected devices from being shipped. The firm initiated contact with implanting facilities in the United States on May 6, 2011 and international facilities and distributors on May 10, 2011 to remove product from the field that has not yet been implanted. Additionally, a "Field Safety Alert" letter was sent to all affected medical professionals. The letter identifies the affected product, the issue, and the action(s) to be taken by the physicians. Consignees are instructed to complete and return an attached Effectiveness Check Form. If assistance is needed physicians may contact Clinical Technical Support at 866-882-8804 or via email at [email protected]
Quantity in commerce: 13 units
Distribution: Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Serial #'s: 2220, 4966, 5035, 8816, 8830, 8878, 9476, 9478, 12422, 12533, 23423, 23460, and 25434.

Product code LYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)