Cyberonics, Inc: FDA recalls

FDA enforcement events from 2014 to 2017; export dated 3 Nov 2026. The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Cyberonics, Inc as the recalling firm in 8 events. The events have 9 product records. The recalls started from 2014 to 2017. All the events are device recalls. By FDA enforcement events, Cyberonics, Inc is number 442 of 1,628 firms that have a page. Events that Cyberonics, Inc started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

See the 8 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 3 Nov 2026.

Enforcement events

8 events, newest first.

FDA enforcement events of Cyberonics, Inc
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

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Cyberonics, Inc: events for each product type
Type		Events
Device		8

Cyberonics, Inc: events in each class
Class		Events
Class II		8

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Cyberonics, Inc, by the year that the recall started. The largest year is 2015, with 4 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Cyberonics, Inc: FDA recalls. https://recallregister.com/firm/cyberonics-inc/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
State of the firm address: TX

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Cyberonics, Inc have?: Class II: 8 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Cyberonics, Inc?: FDA event 78914, which the firm started on 2 Dec 2017. The first product in the record is: 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…
How many FDA recalls of Cyberonics, Inc have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.