Events

Recall of COMPANION 2 DRIVER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNCARDIA SYSTEMS LLC.

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
    42241
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-21
  • 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
    Notification to surgeons of a possible safety risk for patients requiring preimplant circulatory rescue intervention. pre-liminary data analysis from intermacs companion post approval study suggests there may be a higher mortality rate when patient supported by the c2 driver system.

Device

COMPANION 2 DRIVER SYSTEM
  • Model / Serial
    Model Catalog: 397002-001 (Lot serial: N/A)
  • Product Description
    SynCardia Companion 2 Driver System
  • Manufacturer
    SYNCARDIA SYSTEMS LLC

Manufacturer

SYNCARDIA SYSTEMS LLC
  • Manufacturer Address
    TUCSON
  • Source
    HC