Cyberonics, Inc Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.
Brand
Cyberonics, Inc
Lot Codes / Batch Numbers
Model 250, VNS Therapy Programming M250 Programming System, version 4.6, 6.1, 7.0 or 7.1 labeling
Products Sold
Model 250, VNS Therapy Programming M250 Programming System, version 4.6, 6.1, 7.0 or 7.1 labeling
Cyberonics, Inc is recalling Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 due to Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Mod. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists.
Recommended Action
Per FDA guidance
Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take. Labeling updates are being developed concurrently with the notification. The firm will mail or hand-deliver the notifications via firm representatives.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026