Cyberonics, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 23
At a glance
Market reach
- United States
- FDA recalls
What Cyberonics, Inc. makes
Cyberonics, Inc. manufactures the Model 220 Patient Magnet, a handheld device used for external deactivation of implanted vagus nerve stimulators.
The Model 220 Patient Magnet is classified as a Class I medical device in the U.S. and is listed under FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Model 220 Patient Magnet Ref K092364
510(k) 510(k)
FDA recalls
FDA recall records list 23 recalls initiated by Cyberonics, Inc., the earliest on 2006-10-17 and the most recent on 2017-12-02. By recorded status: 23 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 4
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 2 Dec 2017 Z-0555-2018 Class II Terminated Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
- 13 Nov 2017 Z-2255-2018 Class II Terminated Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
- 13 Jun 2017 Z-3019-2017 Class II Terminated Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Full distribution text
- 13 Jun 2017 Z-3020-2017 Class II Terminated Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Full distribution text
2015
- 18 Dec 2015 Z-0659-2016 Class II Terminated Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Full distribution text
- 18 Nov 2015 Z-0645-2016 Class II Terminated Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
- 7 Oct 2015 Z-0280-2016 Class II Terminated Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
- 6 Mar 2015 Z-1526-2015 Class II Terminated 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.
- 18 Dec 2015 Z-0659-2016 Class II Terminated Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
2014
- 20 Nov 2014 Z-0858-2015 Class II Terminated The recalled product was distributed with an incorrect serial number printed on the device's label.
2011
- 12 Aug 2011 Z-0210-2012 Unclassified (pre-2012) Terminated The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.
Full distribution text
- 12 Aug 2011 Z-0210-2012 Unclassified (pre-2012) Terminated The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.
Show all 23 recalls
2011
- 6 May 2011 Z-0005-2012 Unclassified (pre-2012) Terminated An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.
Full distribution text
- 6 May 2011 Z-0006-2012 Unclassified (pre-2012) Terminated An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.
Full distribution text
- 6 May 2011 Z-0005-2012 Unclassified (pre-2012) Terminated An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.
2010
- 6 Apr 2010 Z-1591-2010 Unclassified (pre-2012) Terminated Battery life projection is inaccurate.
2009
- 20 Nov 2009 Z-0642-2010 Unclassified (pre-2012) Terminated Under certain conditions, product's battery life can be reduced.
Full distribution text
- 24 Jul 2009 Z-0264-2010 Unclassified (pre-2012) Terminated Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists.
Full distribution text
- 20 Nov 2009 Z-0642-2010 Unclassified (pre-2012) Terminated Under certain conditions, product's battery life can be reduced.
2008
- 7 Feb 2008 Z-0994-2009 Unclassified (pre-2012) Terminated Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.
- 7 Feb 2008 Z-0995-2009 Unclassified (pre-2012) Terminated Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.
2007
- 25 Oct 2007 Z-0568-2008 Unclassified (pre-2012) Terminated Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.
Full distribution text
- 2 Aug 2007 Z-0171-2008 Unclassified (pre-2012) Terminated Dissolution/Fractures to the leads of the VNS Therapy System
Full distribution text
- 2 Aug 2007 Z-0172-2008 Unclassified (pre-2012) Terminated Dissolution/Fractures to the leads of the VNS Therapy System
Full distribution text
- 2 Aug 2007 Z-0173-2008 Unclassified (pre-2012) Terminated Dissolution/Fractures to the leads of the VNS Therapy System
Full distribution text
- 25 Oct 2007 Z-0568-2008 Unclassified (pre-2012) Terminated Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.
2006
- 17 Oct 2006 Z-0341-2007 Unclassified (pre-2012) Terminated During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
Full distribution text
- 17 Oct 2006 Z-0342-2007 Unclassified (pre-2012) Terminated During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
Full distribution text
- 17 Oct 2006 Z-0341-2007 Unclassified (pre-2012) Terminated During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
Frequently asked questions
How many devices does Cyberonics, Inc. have in the registry?
The registry currently lists 1 device for Cyberonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cyberonics, Inc.'s devices?
Among its 1 most recently registered device, Cyberonics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cyberonics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cyberonics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Cyberonics, Inc.?
FDA recall records list 23 recalls initiated by Cyberonics, Inc., the most recent initiated on 2017-12-02. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cyberonics, Inc. in the registry?
The most recently registered devices listed for Cyberonics, Inc. include MODEL 220 PATIENT MAGNET.