VNS Therapy Demipulse Generator, Model 103 and recallZ-1591-2010 · Cyberonics, Inc · initiated Apr 6, 2010
Terminated All recalls posted in May 2010
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
Battery life projection is inaccurate.
FDA root cause category: Software design
What the company is doing
Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic. The issue can also be corrected during the initial implant procedure with the instructions provided. Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.
Recall details
- Recall number
- Z-1591-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 6, 2010
- Posted by the FDA
- May 10, 2010
- Recalling firm
- Cyberonics, Inc
- Quantity
- Model103: 8109 units; Model 104: 1722 units; Programmers: 8891
- Product code
- LYJ
- FDA submissions
- P970003
- Distribution
- Worldwide distribution.
Product description
VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software
Code information (models, lots, serial numbers)
Model 103, VNS Therapy Demipulse Generator Model 104, VNS Therapy Demipulse Duo Generator Model 250, Programming System (version 7.0 or 7.1)
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.
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