Events

Recall of BIPAP AUTOSV WITH SMARTCARD INT

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
    51661
  • Event Risk Class
    II
  • 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
    Resmed has issued an urgent field safety notice that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a resmed adaptive servo ventilation (asv) therapy compared to the control group. in the patient population with reduced left ventricular ejection fraction (lvef = 45%) 10.0 percent of the asv group experienced a cardiovascular death each year compared to 7.5 percent of the control group representing a 33.5 percent relative increased risk of cardiovascular mortality (hr=1.335 95%ci=(1.070 1.666) p-value= 0.010).

Device

BIPAP AUTOSV WITH SMARTCARD INT
  • Model / Serial
    Model Catalog: 1044114 (Lot serial: ALL); Model Catalog: 1038916 (Lot serial: ALL); Model Catalog: 1044288 (Lot serial: ALL); Model Catalog: 1040718 (Lot serial: ALL); Model Catalog: 1044235 (Lot serial: ALL); Model Catalog: 1008628 (Lot serial: ALL); Model Catalog: CA1008628 (Lot serial: ALL); Model Catalog: 1044280 (Lot serial: ALL); Model Catalog: CA951S (Lot serial: ALL); Model Catalog: CA961S (Lot serial: ALL); Model Catalog: CA951HS (Lot serial: ALL); Model Catalog: CA961TS (Lot serial: ALL); Model Catalog: CA961NTS (Lot serial: ALL); Model Catalog: CA961HS (Lot serial: ALL); Model Catalog: 1044289 (Lot serial: ALL); Model Catalog: 1043343 (Lot serial: ALL); Model Catalog: 1111124 (Lot serial: ALL); Model Catalog: 1010771 (Lot serial: ALL); Model Catalog: 1044278 (Lot serial: ALL); Model Catalog: 1111122 (Lot serial: ALL)
  • Product Description
    BIPAP AUTOSV WITH SMARTCARD INT
  • Manufacturer
    VITALAIRE CANADA INC.

Manufacturer

VITALAIRE CANADA INC.