Handhelds-Cyberonics VNS Therapy System, Model… recallZ-0342-2007 · Cyberonics, Inc · initiated Oct 17, 2006
Terminated All recalls posted in January 2007
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
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
FDA root cause category: Other
What the company is doing
Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.
Recall details
- Recall number
- Z-0342-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 17, 2006
- Posted by the FDA
- Jan 25, 2007
- Recalling firm
- Cyberonics, Inc
- Quantity
- 7,404 Handheld PCs pre-programmed with software.
- Product code
- LYJ
- FDA submissions
- P970003
- Distribution
- Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
Product description
Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Code information (models, lots, serial numbers)
For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600.
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 36672).
- Z-0341-2007 · TerminatedCyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
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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