Device recall: VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

FDA enforcement event 70804 · Class II · initiated 6 Mar 2015 · status Terminated · terminated 9 Oct 2015

DeviceVoluntary: Firm initiated1 product recordHouston, TX

Cyberonics, Inc (Houston, TX) initiated this device recall on 6 Mar 2015; FDA lists 1 product record under event 70804, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 9 Oct 2015. Initiation: voluntary: firm initiated. Cyberonics, Inc has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Cyberonics, Inc, Houston, TX.

Reason for recall

"The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture."

Distribution

"AR, TX, GA, CA, MI, IN, FL, AZ, NV"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1526-2015	VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.	13 units	Class II	Terminated	6 May 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Cyberonics, Inc

Initiated	Product (first record)	Type	Class	Records
2 Dec 2017	VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use:	Device	Class II	1
13 Nov 2017	VNS Therapy Programmer, Model 3000, v1.0 System	Device	Class II	1
13 Jun 2017	VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indicati	Device	Class II	2
18 Dec 2015	VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizur	Device	Class II	1
18 Nov 2015	Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106	Device	Class II	1
7 Oct 2015	Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106	Device	Class II	1
20 Nov 2014	Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS	Device	Class II	1

All 8 events for Cyberonics, Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "AR, TX, GA, CA, MI, IN, FL, AZ, NV"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Oct 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.