Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR… recallZ-0645-2016 · Cyberonics, Inc · initiated Nov 18, 2015
Class II Terminated All recalls posted in January 2016
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
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.
FDA root cause category: Manufacturing material removal
What the company is doing
Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804
Recall details
- Recall number
- Z-0645-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 18, 2015
- Posted by the FDA
- Jan 13, 2016
- Recalling firm
- Cyberonics, Inc
- Quantity
- 29 units
- Product code
- LYJ
- FDA submissions
- P970003
- Distribution
- US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Product description
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Code information (models, lots, serial numbers)
Serial numbers 36602, 37019, 39097, 40311, 40465
Other devices under the same FDA submission
23 devices cleared under P970003 — the recall does not name any of them by identifier. 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® AspireSR® Model 106 GeneratorLivanova USA, Inc. · Stimulator, Autonomic Nerve, Implanted For Epilepsy1 recall151 deaths2,934 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
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 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page