Z-0342-2007

Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1...

Name: Z-0342-2007 Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1...
Creator: Cyberonics, Inc
Published: 2006-10-17
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2006-10-17 / Terminated

FDA source

Cyberonics, Inc began a recall of Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics... on 2006-10-17. The reason FDA records is "During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0342-2007
Status: Terminated
Initiated: 2006-10-17
Posted: 2007-01-25
Terminated: 2009-10-02
Recalling firm: LivaNova USA, Inc.
Product: Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
FDA root cause: Other
Action: Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.
Quantity in commerce: 7,404 Handheld PCs pre-programmed with software.
Distribution: Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
Product codes and lots: For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600.

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