Z-0659-2016Class II

VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the...

Name: Z-0659-2016 VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the...
Creator: Cyberonics, Inc
Published: 2015-12-18
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2015-12-18 / Terminated / root cause: design

FDA source

Cyberonics, Inc began a recall of VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures on 2015-12-18. FDA classified it as Class II and gives the reason as "Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0659-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-01-15
Terminated: 2017-03-02
Recalling firm: LivaNova USA, Inc.
Product: VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified consignees of the issue via letter on 12/18/15. The letter identified the affected device, the issue involved, and actions to be taken. Physicians are to contact Clinical Technical Support at 866-882-8804 to report if a patient's generator has been disabled due to the issue identified. Users are to complete and return the effectiveness card as soon as possible. If further information is needed, customers can contact Clinical Technical Support at 866-882-8804 or via e-mail at [email protected].
Quantity in commerce: 4,935 units
Distribution: Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
Product codes and lots: All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0659-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0659-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)