Events

Recall of VNS THERAPY SYSTEM - PROGRAMMABLE GENERATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

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
    47216
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Livanova is notifying customers that certain model 105 aspirehc and model 106 aspiresr vns therapy generators are subject to the potential for reduced battery longevity associated with the manufacturing process used to assemble the circuit board. physicians of patients with implanted devices are being notified to monitor their impacted patient(s) frequently to check battery status. only model 105 devices were imported and distributed in canada.

Device

VNS THERAPY SYSTEM - PROGRAMMABLE GENERATOR
  • Model / Serial
    Model Catalog: 105 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    VNS THERAPY MODEL 105 ASPIREHC GENERATOR
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC