Events

Recall of ORCHESTRA PROGRAMMER

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
    20102
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-25
  • 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
    Sorin is notifying users of the overestimation of residual longevity displayed by orchestra and orchestra plus programmers during follow-up exams of patients implanted with reply and esprit rate responsive pacemakers. because of the incorrect information the follow-up dates might not have been adjusted when nearing the eri (elective replacement indicator). when the device approaches the eri this overestimation could result in eri or eol (end of life) being reached between two follow-up visits.

Device

ORCHESTRA PROGRAMMER
  • Model / Serial
    Model Catalog: ORCHESTRA (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: ORCHESTRA PLUS (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    ORCHESTRA PROGRAMMER
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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