Cyberonics Recalls
9 recalls on record · December 31, 2014 to June 27, 2018 · Medical Devices
Recalls by year
14
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16
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18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 27, 2018Medical DevicesFDA
Cyberonics, Inc recalls VNS Therapy Programmer, Model 3000, v1.0 System
Hazard: 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).
February 14, 2018Medical DevicesFDA
Cyberonics, Inc recalls VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications fo
Hazard: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
August 23, 2017Medical DevicesFDA
Cyberonics, Inc recalls VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Ind
Hazard: Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
August 23, 2017Medical DevicesFDA
Cyberonics, Inc recalls VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Ind
Hazard: Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
January 27, 2016Medical DevicesFDA
Cyberonics, Inc recalls VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of sei
Hazard: 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.
January 27, 2016Medical DevicesFDA
Cyberonics, Inc recalls Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Hazard: 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.
November 25, 2015Medical DevicesFDA
Cyberonics, Inc recalls Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Hazard: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
May 6, 2015Medical DevicesFDA
Cyberonics, Inc recalls VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Hazard: 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.
December 31, 2014Medical DevicesFDA
Cyberonics, Inc recalls Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS
Hazard: The recalled product was distributed with an incorrect serial number printed on the device's label.