Z-0858-2015Class II

Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the...

Name: Z-0858-2015 Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the...
Creator: Cyberonics, Inc
Published: 2014-11-20
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2014-11-20 / Terminated / root cause: labeling and UDI

FDA source

Cyberonics, Inc began a recall of Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy... on 2014-11-20. FDA classified it as Class II and gives the reason as "The recalled product was distributed with an incorrect serial number printed on the device's label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0858-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Posted: 2014-12-23
Terminated: 2016-02-08
Recalling firm: LivaNova USA, Inc.
Product: Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. 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: The recalled product was distributed with an incorrect serial number printed on the device's label.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.
Quantity in commerce: 1 unit
Distribution: Distributed to PA.
Product codes and lots: Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0858-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0858-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

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)