VNS Therapy AspireSR Generator Model 106 recallZ-0659-2016 · Cyberonics, Inc · initiated Dec 18, 2015
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cyberonics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
The firm notified consignees of the issue via letter on 12/18/15. The letter identified the affected device, the issue involved, and actions to be taken. Physicians are to contact Clinical Technical Support at 866-882-8804 to report if a patient's generator has been disabled due to the issue identified. Users are to complete and return the effectiveness card as soon as possible. If further information is needed, customers can contact Clinical Technical Support at 866-882-8804 or via e-mail at [email protected].
Recall details
- Recall number
- Z-0659-2016
- Status
- Terminated
- Initiated by the company
- Dec 18, 2015
- Posted by the FDA
- Jan 15, 2016
- Recalling firm
- Cyberonics, Inc
- Quantity
- 4,935 units
- Product code
- LYJ
- FDA submissions
- P970003
- Distribution
- Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
Product description
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Code information (models, lots, serial numbers)
All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VNS Therapy® AspireSR® Model 106 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted For Epilepsy1 recall151 deaths2,934 reports
Other devices under the same FDA submission
22 devices cleared under P970003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VNS Therapy® SenTiva™ Model 1000 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted For Epilepsy3 recalls188 deaths3,378 reports
- VNS Therapy® PerenniaFLEX® Model 304 Lead 304-20Livanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)1 death1,614 reports
- VNS Therapy® Demipulse® Model 103 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)24 deaths371 reports
- VNS Therapy® AspireHC® Model 105 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)1 recall17 deaths307 reports
- VNS Therapy® Demipulse Duo® Model 104 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)20 deaths266 reports
- VNS Therapy® PerenniaDURA® Model 303 Lead 303-20Livanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)1 recall181 reports
- VNS Therapy® Symmetry™ Model 8103 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)8 deaths223 reports
- VNS Therapy® Model 302 Lead 302-20Livanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)161 reports
- VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)2 recalls4 deaths28 reports
- VNS Therapy® PerenniaFLEX® Model 304 Lead 304-30Livanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)108 reports
- VNS Therapy® Pulse Model 102 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)6 deaths81 reports
- VNS Therapy® Programmer, Model 3000 v1.5Livanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted (Depression)51 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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