Z-0172-2008

Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc...

Name: Z-0172-2008 Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc...
Creator: Cyberonics, Inc
Published: 2007-08-02
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2007-08-02 / Terminated / root cause: manufacturing process

FDA source

Cyberonics, Inc began a recall of Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058 on 2007-08-02. The reason FDA records is "Dissolution/Fractures to the leads of the VNS Therapy System". 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-0172-2008
Status: Terminated
Initiated: 2007-08-02
Posted: 2007-11-28
Terminated: 2009-10-05
Recalling firm: LivaNova USA, Inc.
Product: Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: Dissolution/Fractures to the leads of the VNS Therapy System
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
Quantity in commerce: 34,719 units.
Distribution: Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Malta, Mexico, Netherlands, Northern Ireland, Norway, Poland, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
Product codes and lots: All manufactured and distributed leads.

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)