Events

Recall of PERCEVAL S HEART VALVE

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
    17076
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-08
  • 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
    Since initial market introduction of the perceval valve livanova has continued to gather feedback from users regarding critical procedural steps requiring careful execution in order to reduce the possibility of intraoperative complications such as valve malpositioning significant perivalvular or central regurgitation and permanent pacemaker implantation. following some cases of intra/peri-operative central leak livanova is providing clarifications on the implantation steps in order to integrate information addressed in the instructions for use and the inservice guide.

Device

PERCEVAL S HEART VALVE
  • Model / Serial
    Model Catalog: PVS23 (Lot serial: ALL); Model Catalog: PVS21 (Lot serial: ALL)
  • Product Description
    PERCEVAL SUTURELESS HEART VALVE
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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