Cyberonics, Inc Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058.
Brand
Cyberonics, Inc
Lot Codes / Batch Numbers
All manufactured and distributed leads.
Products Sold
All manufactured and distributed leads.
Cyberonics, Inc is recalling Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberoni due to Dissolution/Fractures to the leads of the VNS Therapy System. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dissolution/Fractures to the leads of the VNS Therapy System
Recommended Action
Per FDA guidance
Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
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