Events

Recall of Cyberonics VNS Therapy AspireSR Generator Model 106

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cyberonics, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72385
  • Event Risk Class
    Class 2
  • Event Number
    Z-0280-2016
  • Event Initiated Date
    2015-10-07
  • Event Date Posted
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140876
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
  • Reason
    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
    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.

Device

Cyberonics VNS Therapy AspireSR Generator Model 106
  • Model / Serial
    Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
  • Manufacturer
    Cyberonics, Inc

Manufacturer

Cyberonics, Inc
  • Manufacturer Address
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA