Dive Brief:

• FDA has categorized a recall of Philips Respironics V60 and V60 Plus ventilators as a Class I event after reviewing 25 injuries linked to the devices.
• The recall was triggered by identification of a risk that ventilators upgraded to enable high flow therapy may provide the patient with lower oxygen flow rate. Decreases in flow rate can cause oxygen desaturation, respiratory distress and ultimately clinical deterioration.
• Philips is asking users of the V60 devices to continuously monitor the oxygen saturation of patients and to not use high flow therapy if constant, close monitoring is impossible. FDA has reports of 61 incidents, 25 injuries and zero deaths. The Class I event is separate from FDA's designation in late July of a recall impacting millions of Philips sleep apnea and ventilator devices. 

Dive Insight:

The V60 and V60 Plus ventilators are outside of the scope of the sound abatement foam recall that is now underway at Philips, which a Baird analysts estimates could cost the company about $800 million in revenue.

However, on June 18 Philips initiated a separate recall covering versions of the ventilators that are equipped to provide a high concentration of oxygen at a higher flow rate than is typical.

Philips began the recall after identifying a problem that can occur when the pressure reaches the upper limit. At that point, the ventilator sounds an alarm and lowers the pressure, thereby causing the flow rate to fall. The reduction in the flow rate could stop the patient from receiving the oxygen they need, which FDA said could lead to serious adverse events including death. 

The potential for serious harm and death led FDA to categorize the recall as a Class I event. The recall covers 16,535 devices that were distributed in the U.S. between May 2009 and June 2021. 

Philips is keeping the affected devices on the market but asking users to take precautions. The goal of the recommendations is to ensure any alarms or changes in oxygen saturation are quickly identified and acted on by healthcare professionals to prevent dangerous drops in blood oxygen levels.

The company has updated its manual and created a video to educate healthcare professionals about the risk.  

The recall adds to the focus on the performance of respiratory devices made by Philips. In the second quarter, Philips suffered a double-digit drop in sleep and respiratory care sales as orders of systems affected by the sound abatement foam recall stopped, handing a potential opportunity to competitor ResMed.

The V60 recall is far smaller but is still another issue for a company that has had quality problems in the past, notably when it agreed to a consent decree with FDA about external defibrillators.

Philips' stock price was down nearly 4% when the U.S. market opened Wednesday. Shares have dropped by approximately 22% since the June 14 recall was announced.