Adaptive Servo-Ventilation (AVS) Therapy devices (2015-05-13)

Starting date:

May 13, 2015

Posting date:

June 12, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53771

• Reason
• Affected products

Recalled Products

A. VPAP Adapt SV / SV Enhanced
B. AutoSet CS
C. VPAP Tx / Tx Clinical System Kit
D. S9 VPAP Adapt
E. S9 VPAP Adapt + H5i
F. S9 VPAP Adapt + Climate Control
G. AutoSet CS2
H. VPAP Adapt/Adapt+H5i/Adapt+Climate Control
I. S9 VPAP Tx/Tx Clinical System Kit/Tx Americas
J. Lumis Tx
K. Lumis Tx + H5i
L. AirCurve 10 ASV USA TRI
M. AirCurve 10 ASV USA CO
 

Reason

Serious safety concern identified in patients with symptomatic, chronic heart failure with reduced left ventricular ejection fraction while on ASV therapy. At risk patients are at a 33.5% increased risk of cardiovascular death while on ASV therapy.

Affected products