Events

Recall of ESPRIT DR RATE RESPONSIVE DUAL CHAMBER PACEMAKER

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
    21685
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-03
  • 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
    When an implanted device approaches the recommended replacement time (rrt) the residual longevity estimate provided by the programmer at follow-up may be overestimated which could result in reaching rrt between two follow-up visits. until a new programmer software version is approved livanova is providing a number of patient management recommendations.

Device

ESPRIT DR RATE RESPONSIVE DUAL CHAMBER PACEMAKER
  • Model / Serial
    Model Catalog: ESPRIT DR (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: REPLY 200 SR (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: REPLY 200 DR (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: REPLY SR (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: ESPRIT SR (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: REPLY DR (Lot serial: >1000 NUMBERS CONTACT MFR)
  • Product Description
    ESPRIT DR PACEMAKER;REPLY 200 SR PACEMAKER;REPLY 200 DR PACEMAKER;REPLY SR PACEMAKER;ESPRIT SR PACEMAKER;REPLY DR PACEMAKER
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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