CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report

VNS Therapy AspireHC recalled by Cyberonics

Cyberonics is recalling Cyberonics VNS Therapy AspireHC, distributed in Pennsylvania. The recall was initiated on 20 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0858-2015
FDA event ID: 69844
Recalling firm: Cyberonics, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2014
FDA classified: 23 Dec 2014
Reported: 31 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

20 Nov 2014	Recall initiated by company
23 Dec 2014	Classified by FDA	+33 days
31 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The recalled product was distributed with an incorrect serial number printed on the device's label.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

Distributed to PA.

Pennsylvania

Questions about this recall

Is VNS Therapy AspireHC recalled?

Yes. Cyberonics recalled VNS Therapy AspireHC on 20 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0858-2015.

Why was it recalled?

The recalled product was distributed with an incorrect serial number printed on the device's label.

Which lots are affected?

Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Where was it sold?

Distributed to PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cyberonics

All 9

Reported	Class	Recall	Company	Reason	Where
27 Jun 2018Device	CLASS II	VNS Therapy Programmer recalled by Cyberonics	Cyberonics	Lead & Heavy Metals	21 states
14 Feb 2018Device	CLASS II	VNS(R) Therapy Programmer, GMDN recalled by Cyberonics	Cyberonics	Device Malfunction	CO, ND
23 Aug 2017Device	CLASS II	VNS Therapy¿ AspireHC¿ Generator recalled by Cyberonics	Cyberonics	Other	Nationwide
23 Aug 2017Device	CLASS II	VNS Therapy¿ AspireHC¿ Generator recalled by Cyberonics	Cyberonics	Other	Nationwide
27 Jan 2016Device	CLASS II	Vagus Nerve Stimulator VNS Therapy AspireSR Generator recalled	Cyberonics	Device Malfunction	Nationwide

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