Z-0645-2016Class II

Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

Name: Z-0645-2016 Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Creator: Cyberonics, Inc
Published: 2015-11-18
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2015-11-18 / Terminated / root cause: manufacturing process

FDA source

Cyberonics, Inc began a recall of Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 on 2015-11-18. FDA classified it as Class II and gives the reason as "Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity". 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-0645-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2016-01-13
Terminated: 2017-09-06
Recalling firm: LivaNova USA, Inc.
Product: Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804
Quantity in commerce: 29 units
Distribution: US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Product codes and lots: Serial numbers 36602, 37019, 39097, 40311, 40465

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0645-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0645-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-19

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)