Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of LivaNovaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Cyberonics with 9 device recalls and 1 510(k) clearance. The most recent is a device recall dated Dec 2, 2017: VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indicatio….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 2, 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : ThClass II · Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. | Device recalls |
| Nov 13, 2017 | VNS Therapy Programmer, Model 3000, v1.0 SystemClass II · Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and | Device recalls |
| Jun 13, 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: EpClass II · Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected | Device recalls |
| Jun 13, 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: EpClass II · Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected | Device recalls |
| Dec 18, 2015 | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.Class II · Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 Aspi | Device recalls |
| Nov 18, 2015 | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106Class II · Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature | Device recalls |
| Oct 7, 2015 | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106Class II · Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature | Device recalls |
| Mar 6, 2015 | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.Class II · The pulse generators have a lower battery longevity than specified in their design requirement as a result of the device | Device recalls |
| Nov 3, 2009 | MODEL 220 PATIENT MAGNETK092364 · DTG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
