Cyberonics, Inc: VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. Electrical signals are delivered from the Demipulse Generator to the vagus nerve by the lead. The lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The external programming system includes the Programming Wand, the programming software, and a compatible computer. The programming software is used with the Programming Wand to allow a physician to read and change the Demipulse Generator settings transcutaneously. 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.

Recall number

Z-0642-2010

Recalling firm

Cyberonics, Inc

Product

VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. Electrical signals are delivered from the Demipulse Generator to the vagus nerve by the lead. The lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The external programming system includes the Programming Wand, the programming software, and a compatible computer. The programming software is used with the Programming Wand to allow a physician to read and change the Demipulse Generator settings transcutaneously. 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.

Status

Terminated

Initiated

2009-11-20

Posted

2010-01-14

Terminated

2012-07-24

Reason

Under certain conditions, product's battery life can be reduced.

Root cause

Other

Action

Firm sent "An Important Safety Notice" letter to all physicians explaining events, risks presented and recommended actions. Letter was mailed November 20, 2009. Physicians should complete and return the effectiveness card as soon as possible to acknowledge that you have read and understood the Safety Alert Letter. If further information is needed, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.

Quantity

8,667 units

Distribution

Worldwide Distribution -- USA, Argentina, Austria, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Iceland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Panama, Portugal, Republic of Germany, Saudi Arabia, Sweden, Slovakia, Spain, Switzerland, Taiwan, UAE, United Kingdom, and Venezuela.

Lot, serial or model codes

Model 103: Manufactured from 1/25/2007 - present; Model 104: Manufactured from 1/25/2007 - present.

510(k) numbers

not on file

PMA numbers

not on file

Product code

LYJ

Firm FEI

1000117004

Firm city

Houston

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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