Events

Recall of VPAP ADAPT SV

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VITALAIRE CANADA INC..

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
    101419
  • Event Risk Class
    I
  • Event Initiated Date
    2015-07-06
  • 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
    A serious safety concern has been identified during the preliminary primary data analysis from the serve-hf clinical trial. this trial investigated the effect of adaptive servo- ventilation (asv) therapy on the hospitalization and mortality rate of patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef = 45%) and moderate to severe predominant central sleep apnea (ahi ? 15/h cahi/ahi ? 50% and cai ? 10/h).

Device

VPAP ADAPT SV
  • Model / Serial
    Model Catalog: 26013 (Lot serial: ); Model Catalog: 26008 (Lot serial: ); Model Catalog: 36007 (Lot serial: ); Model Catalog: 36007A (Lot serial: ); Model Catalog: 36057 (Lot serial: ); Model Catalog: 36047 (Lot serial: ); Model Catalog: 36037 (Lot serial: ); Model Catalog: 25107 (Lot serial: ); Model Catalog: 25102 (Lot serial: ); Model Catalog: 37216 (Lot serial: ); Model Catalog: 26002 (Lot serial: ); Model Catalog: 37215 (Lot serial: ); Model Catalog: 36017 (Lot serial: ); Model Catalog: 36027 (Lot serial: ); Model Catalog: 36000 (Lot serial: ); Model Catalog: 36050 (Lot serial: ); Model Catalog: 36010 (Lot serial: ); Model Catalog: 36048 (Lot serial: ); Model Catalog: 25005 (Lot serial: ); Model Catalog: 36058 (Lot serial: )
  • Product Description
    VPAP ADAPT SV
  • Manufacturer
    VITALAIRE CANADA INC.

Manufacturer

VITALAIRE CANADA INC.