Cyberonics, Inc Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.
Brand
Cyberonics, Inc
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Cyberonics, Inc is recalling Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus ner due to Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026