Cyberonics, Inc
Medical device manufacturer in Houston, TX.
1510(k) clearances
0PMA approvals
23recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K092364 | Model 220 Patient MagnetDTG · Traditional | 11/03/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0555-2018 Class II | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications:…Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. | 12/02/2017Terminated |
| Z-2255-2018 Class II | VNS Therapy Programmer, Model 3000, v1.0 SystemCertain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103… | 11/13/2017Terminated |
| Z-3020-2017 Class II | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 106. Product…Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster… | 06/13/2017Terminated |
| Z-3019-2017 Class II | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product…Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster… | 06/13/2017Terminated |
| Z-0659-2016 Class II | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in…Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the… | 12/18/2015Terminated |
| Z-0645-2016 Class II | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat… | 11/18/2015Terminated |
| Z-0280-2016 Class II | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat… | 10/07/2015Terminated |
| Z-1526-2015 Class II | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model…The pulse generators have a lower battery longevity than specified in their design requirement as a result… | 03/06/2015Terminated |
| Z-0858-2015 Class II | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System…The recalled product was distributed with an incorrect serial number printed on the device's label. | 11/20/2014Terminated |
| Z-0210-2012 | VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics…The devices are being recalled because the output current delivered to the vagus nerve is less than the… | 08/12/2011Terminated |
| Z-0006-2012 | Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104…An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator… | 05/06/2011Terminated |
| Z-0005-2012 | VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103…An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator… | 05/06/2011Terminated |
| Z-1591-2010 | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator…Battery life projection is inaccurate. | 04/06/2010Terminated |
| Z-0642-2010 | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator…Under certain conditions, product's battery life can be reduced. | 11/20/2009Terminated |
| Z-0264-2010 | Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version…Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare… | 07/24/2009Terminated |
| Z-0995-2009 | Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable…Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet… | 02/07/2008Terminated |
| Z-0994-2009 | Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable…Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet… | 02/07/2008Terminated |
| Z-0568-2008 | Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5…Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the… | 10/25/2007Terminated |
| Z-0173-2008 | Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed…Dissolution/Fractures to the leads of the VNS Therapy System | 08/02/2007Terminated |
| Z-0172-2008 | Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed…Dissolution/Fractures to the leads of the VNS Therapy System | 08/02/2007Terminated |
| Z-0171-2008 | Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile…Dissolution/Fractures to the leads of the VNS Therapy System | 08/02/2007Terminated |
| Z-0342-2007 | Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with…During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range… | 10/17/2006Terminated |
| Z-0341-2007 | Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1…During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range… | 10/17/2006Terminated |