Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
FDA Recall Z-0280-2016 · Posted 2015-11-17
Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2015-10-07
Date Terminated2017-09-06
Product Quantity27 units
Reason for Recall
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Firm Action
Cyberonics sent written recall notifications beginning October 14, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer.
The notice also directs customers to contact Cyberonics to schedule additional on-site troubleshooting. The on-site troubleshooting proposed by Cyberonics will utilize a feature included within the Model 250 Version 9.0 Programming Software as an alternate method of verifying heart rate and determining that the appropriate heart beat sensitivity setting is programmed. The Version 9.0 software displays an instantaneous heart rate when the user selects the 'Refresh' feature. This heart rate is measured directly by the generator and displayed on the programmer.
For further questions, please call (866) 882-8804.
Root Cause
Manufacturing material removal
Distribution Pattern
US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.