Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

FDA device recall Z-0280-2016 · posted 2015-11-17 · Terminated

Recall details

Recalling firm

Cyberonics, Inc

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.

Action taken

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

Status

Terminated

Product code

LYJ

Quantity affected

27 units

Distribution

US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.

Date initiated

2015-10-07

Date posted

2015-11-17

Date terminated

2017-09-06

Location

Houston, TX