The US Food and Drug Administration (FDA) has classified the recall of Vyaire’s respiratory support devices as Class I – the most serious type of recall.
The US company initiated the recall of its AirLife manual resuscitator devices on 6 December 2023. The FDA tagged the recall as Class I – meaning continued device use could result in serious injury or death – on 21 March 2024.
Go deeper with GlobalData
The recall covers more than six and a half million devices and includes nine products from Vyaire’s AirLife range. The devices are single patient-use resuscitators intended for respiratory support.
Vyaire initiated the recall following reports of patients not receiving enough ventilation, potentially resulting in hypoventilation or hypoxia. A total of 37 incidents were reported, including two injuries and two deaths.
Vyaire traced the issue to a manufacturing defect, which it corrected in 2017. However, devices distributed before then could still be in use.
See Also:
In a letter to customers, the company said to discard or destroy the AirLife manual resuscitators.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataVyaire did not immediately respond to Medical Device Network for comment.
Respiratory devices have been a recurrent topic of conversation in recent years amid a slew of recalls. Philips has been one of the main companies under the spotlight following multiple recalls of its ventilator line. Draeger’s ventilators also faced issues, leading to a Class I recall in mid-2023. ResMed recalled more than 20 million of its continuous positive airway pressure (CPAP) masks in late 2023, with the FDA issuing a Class I recall tag in January 2024.
Medtronic caused ripples in the space earlier this year when the company announced it was exiting an “unprofitable” ventilator market.
A report by GlobalData estimates the global anaesthesia and respiratory devices market will grow to just over $19bn by 2033, up from $12.7bn in 2023.
