Cyberonics VNS Therapy Demipulse Duo Generator, Model 104 recallZ-0995-2009 · Cyberonics, Inc · initiated Feb 7, 2008
Terminated All recalls posted in April 2009
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
Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.
FDA root cause category: Software design
What the company is doing
Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered). Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician. If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.
Recall details
- Recall number
- Z-0995-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 7, 2008
- Posted by the FDA
- Apr 22, 2009
- Recalling firm
- Cyberonics, Inc
- Quantity
- 108 units.
- Product code
- LYJ
- FDA submissions
- P970003
- Distribution
- Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.
Product description
Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.
Code information (models, lots, serial numbers)
All lots.
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
Other products in the same recall event
The FDA groups related products into one recall event (event 47442).
- Z-0994-2009 · TerminatedCyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.
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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