Dive Brief:

• Philips is recalling more than 1,200 DreamStation sleep apnea devices again after its work to fix foam insulation created a new problem that poses a serious risk to patients’ health.
• The U.S. Food and Drug Administration has categorized the recall, which began in February, as a Class I event because it can cause the devices to provide the wrong amount of air, or fail to deliver any treatment at all.
• Philips has recalled some 5.5 million respirators over foam insulation that can degrade and enter users’ lungs. The company saw its shares drop as much as 80% since the recall was announced in 2021, though shares have since recovered slightly.

Dive Insight:

Philips’ attempt to repair or replace millions of million respiratory devices in response to risks related to sound abatement foam has created new problems for the company. Last year, the Dutch manufacturer warned that the replacement foam can block the air inlet, and that trace amounts of particulate matter had been found in the air pathway. The problems led to a Class I recall of the repaired devices.

Now, Philips has again recalled some devices covered by the original notice from 2021. The new issue stems from Philips’ assignment of incorrect or duplicate serial numbers to reworked DreamStation sleep apnea devices during initial programming. 

When affected devices connect to the cloud-based care management application, they may be unable to download prescription settings or have the incorrect settings. The problem could result in a patient being treated with different pressure or comfort settings, or not receiving any therapy at all. The DreamStation devices give no warning or indication that they are not providing the doctor-prescribed treatment.

Philips has received 43 complaints about the fault. While none of the reports describe serious injuries or deaths, the FDA said incorrect therapy or therapy failure may lead to “several health conditions such as respiratory failure, heart failure, serious injury and death.” As such, the agency assigned the recall to Class I, its highest risk category.   

The recall affects 1,233 devices distributed in the U.S., France and Reunion, an overseas region of France. Most of the recalled products were distributed in the U.S. between Dec. 2021 and Oct. 2022.  The recall comes as Philips works to wrap up the repair and replacement of the devices covered by the original notice and start to try to regain market share lost to ResMed during the disruption.

Customers and patients should check whether their product is among the affected devices, Philips said in its notice. Patients can continue to use any affected devices until Philips provides them with replacement products.