Events

Recall of ReMed devices used for Adaptive Servo-Ventilation (ASV) TherapyAutoSet CS; AutoSet CS2; VPAP Adapt SV; S9 VPAP Adapt; VPAP Adapt; AirCurve 10 CS PaceWave; VPAP Tx; S9 VPAP Tx

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Resmed Limited.

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
    RC-2015-RN-00405-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00405-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 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 hospitalisation 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. the identified safety concern is a significant increase in the risk of cardiovascular death in patients with symptomatic, chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef = 45%) being treated with adaptive servo-ventilation.
  • Action
    Resmed is advising physicians managing patients who are having symptomatic chronic heart failure with reduced ejection fraction and predominant central sleep apnea who are using ResMed ASV devices that they should contact their patients to discuss discontinuation of treatment. For more details, please see https://www.tga.gov.au/alert/resmed-devices-use-adaptive-servo-ventilation-therapy. This action has been closed-out on 08/08/2016.

Device

ReMed devices used for Adaptive Servo-Ventilation (ASV) TherapyAutoSet CS; AutoSet CS2; VPAP Adap...
  • Model / Serial
    ReMed devices used for Adaptive Servo-Ventilation (ASV) TherapyAutoSet CS (Product Code - 25005)AutoSet CS2 (Product Code - 26001)VPAP Adapt SV (Product Code - 26009)S9 VPAP Adapt (Product Code - 36367)VPAP Adapt (Product Code - 36377)AirCurve 10 CS PaceWave (Product Code - 37354)VPAP Tx (Product Code 25103)S9 VPAP Tx (Product Code 36030)ARTG Number: 118966
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited