| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00405-1 |
| Product Name/Description |
ReMed devices used for Adaptive Servo-Ventilation (ASV) Therapy
AutoSet 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 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 647 259 - ResMed |