Cyberonics, Inc

FDA recalling firm · 8 enforcement events · 9 product records · 2014–2017 · TX

Cyberonics, Inc has 8 FDA enforcement events on this register (9 product records) between 2014 and 2017: 8 device; the busiest year was 2015 with 4.

0% of its events are Class I; the most common class is Class II (8). 0 events are listed as ongoing; the recalling firm's address is in TX.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
2 Dec 2017	VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are…	Device	Class II	1	Terminated
13 Nov 2017	VNS Therapy Programmer, Model 3000, v1.0 System	Device	Class II	1	Terminated
13 Jun 2017	VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with…	Device	Class II	2	Terminated
18 Dec 2015	VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.	Device	Class II	1	Terminated
18 Nov 2015	Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106	Device	Class II	1	Terminated
7 Oct 2015	Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106	Device	Class II	1	Terminated
6 Mar 2015	VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.	Device	Class II	1	Terminated
20 Nov 2014	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.	Device	Class II	1	Terminated

By type and class

Device8

Class II8

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Cyberonics, Inc by year initiated.

Questions and answers

How many FDA recalls has Cyberonics, Inc had?

8 enforcement events (9 product records) on this register, 2014–2017: 8 device.

Are any Cyberonics, Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Cyberonics, Inc recalls?

8 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.