Events

Recall of Device Recall VNS Therapy AspireHC Pulse Generator

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
    69844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0858-2015
  • Event Initiated Date
    2014-11-20
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131684
  • 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
    The recalled product was distributed with an incorrect serial number printed on the device's label.
  • Action
    The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.

Device

Device Recall VNS Therapy AspireHC Pulse Generator
  • Model / Serial
    Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed to PA.
  • Product Description
    Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
  • 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