Events

Recall of PARADYM DR ICD

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
    52974
  • Event Risk Class
    III
  • Event Initiated Date
    2011-05-13
  • 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
    It was discovered that the bills of materials for the packaging of the paradym dr and vr icd models manufactured by sorin crm s.R.L. for canada included a reference to an incorrect patient booklet the icd/crt patient booklet ref o263 instead of the correct booklet the icd patient booklet ref n582.

Device

PARADYM DR ICD
  • Model / Serial
    Model Catalog: 8550 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 8250 (Lot serial: > 10 NUMBERS CONTACT MFR)
  • Product Description
    PARADYM DR ICD
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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