Cyberonics recalls
Cyberonics appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2018-06-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2014-12-31 to 2018-06-27 |
| By agency | FDA Device (9) |
| By classification | Class II (9) |
| By status | terminated (9) |
| Distribution named in notices | AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, ME, MI, MO, MS, NC, ND, NJ, NV, NY, OH, OR, PA, TN, TX, US, UT, WA, WI, WV |
Recalls
- VNS Therapy Programmer, Model 3000, v1.0 System
FDA Device · Class II · 2018-06-27 · Cyberonics
Reason: 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 mo… - VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS…
FDA Device · Class II · 2018-02-14 · Cyberonics
Reason: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. - VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2017-08-23 · Cyberonics
Reason: Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity. - VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2017-08-23 · Cyberonics
Reason: Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity. - VNS Therapy AspireSR Generator Model 106
FDA Device · Class II · 2016-01-27 · Cyberonics
Reason: 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. - Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
FDA Device · Class II · 2016-01-27 · Cyberonics
Reason: 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. - Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
FDA Device · Class II · 2015-11-25 · Cyberonics
Reason: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity. - VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104
FDA Device · Class II · 2015-05-06 · Cyberonics
Reason: 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. - Cyberonics VNS Therapy AspireHC, Model 105 Generator
FDA Device · Class II · 2014-12-31 · Cyberonics
Reason: The recalled product was distributed with an incorrect serial number printed on the device's label.