Cyberonics, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Cyberonics, Inc
Lot Codes / Batch 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.
Products Sold
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.
Cyberonics, Inc is recalling Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v due to During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
Recommended Action
Per FDA guidance
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.
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